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11/7/2025

Pimecrolimus 1% Topical Cream

Products Affected - Description

    • Elidel topical cream, Bausch Health, 1%, 100 gram tube, NDC 00187-5102-03
    • Elidel topical cream, Bausch Health, 1%, 30 gram tube, NDC 00187-5100-01
    • Elidel topical cream, Bausch Health, 1%, 60 gram tube, NDC 00187-5101-02
    • Pimecrolimus topical cream, Glenmark, 1%, 30 gram tube, NDC 68462-0609-35
    • Pimecrolimus topical cream, Teva, 1%, 100 gram tube, NDC 00591-2944-87
    • Pimecrolimus topical cream, Teva, 1%, 30 gram tube, NDC 00591-2944-30
    • Pimecrolimus topical cream, Teva, 1%, 60 gram tube, NDC 00591-2944-60

Reason for the Shortage

    • Bausch Health did not provide a reason for the shortage of Elidel 1% cream. The authorized generic is available.
    • Glenmark's product is pending release due to quality assurance review.
    • Teva did not provide a reason for the shortage.

Available Products

    • Pimecrolimus topical cream, Bausch Health, 1%, 100 gram tube, NDC 68682-0112-03
    • Pimecrolimus topical cream, Bausch Health, 1%, 30 gram tube, NDC 68682-0110-01
    • Pimecrolimus topical cream, Bausch Health, 1%, 60 gram tube, NDC 68682-0111-02
    • Pimecrolimus topical cream, Glenmark, 1%, 100 gram tube, NDC 68462-0609-94
    • Pimecrolimus topical cream, Glenmark, 1%, 60 gram tube, NDC 68462-0609-65

Estimated Resupply Dates

    • Bausch Health has Elidel 1% topical cream in 30 gram, 60 gram, and 100 gram tubes on back order and the company cannot estimate a release date.
    • Glenmark has pimecrolimus 1% cream in 30 gram tubes on back order and the company estimates a release date in late-November 2025.
    • Teva has pimecrolimus 1% cream in 30 gram and 60 gram tubes on back order and the company estimates a release date of mid-January 2026. The 100 gram tubes are on intermittent back order and the company is releasing product as it becomes available.

Implications for Patient Care

    • Pimecrolimus cream is labeled for the treatment of mild-to-moderate eczema in children 2 years and older and adults who are not immunocompromised.1,2 This agent is used as second-line therapy.[1-2]
    • Unlabeled indications include facial and intertriginous and facial psoriasis, oral lichen planus, and vitiligo in the head and neck area.[2]

Safety

    • Use pimecrolimus cream for short-term management or intermittent long-term management.[1-2]

Alternative Agents & Management

    • Moisturizers are recommended as a nonpharmacologic treatment for atopic dermatitis in adults.[3]
    • Pharmacologic alternative therapies for the treatment of eczema in adults include tacrolimus 0.03% or 0.1% ointment, intermittent use of topical corticosteroids, crisaborole ointment, and ruxolitinib cream. The guidelines discuss each class and do not recommend treatment sequence for each class of medication.3 These agents may be used in combination or as monotherapy.[3]
    • Alternative second-line agents for use in children greater than 2 years include tacrolimus ointment.[4] Crisaborole is approved in children 3 months and older, but the guidance does not list line of therapy for this agent.[4-5] Ruxolitinib is approved in children 12 years and older, but the guidance does not list line of therapy for this agent.[4]

References

    1. Pimecrolimus cream [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals, Inc. USA; November 2018.
    2. Pimecrolimus. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed October 14, 2025.
    3. Sidbury R, Alikhan A, Bercovich L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol 2023; 89:e1-20. doi: 10.1016/j.jaad.2022.12.029.
    4. Treatment of atopic dermatitis. American Academy of Pediatrics. Updated June 11, 2021. Accessed October 14, 2025. https://www.aap.org/en/patient-care/atopic-dermatitis/treatment-of-atopic-dermatitis/?srsltid=AfmBOop0PAZbOpLvwdvWB54Yz77CwVri1Bl6cM0SSqSrPdjsekWhBIkK
    5. Eucrisa ointment [prescribing information]. New York, NY: Pfizer Laboratories; September 2025.

Updated

Updated November 7, 2025 by Elyse MacDonald, PharmD, MS, BCPS. Created February 28, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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