Crown Laboratories
NDC labeler code: 0316
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 4 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 3 products
- NystatinNystop, Klayesta, Nyamyc · 1 product
- Nystatin and triamcinolone acetonide1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 26, 2017 | ANDA207730 | Nystatin and triamcinolone acetonide NYSTATIN AND TRIAMCINOLONE ACETONIDE | Crown Labs Inc |
| September 26, 2017 | ANDA207733 | Nystatin NYSTATIN | Crown Labs Inc |
| March 19, 1984 | ANDA088042 | Triamcinolone acetonide TRIDERM | Crown Labs |
| March 9, 1973 | ANDA080706 | Hydrocortisone ALA-CORT | Crown Labs |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2020
-
June 10, 2020 · Class II · Terminated · D-1339-2020 · Nystatin
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
-
June 10, 2020 · Class II · Terminated · D-1338-2020 · Nystatin
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026