Home NDC 51672-2010-2 Hydrocortisone
Product NDC 51672-2010
Requested package NDC 51672-2010-2
11-digit product format 516722010
Labeler code 51672
Product ID 51672-2010_390d0eb8-c4dc-e391-e063-6394a90a7333
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-09-13
Substance HYDROCORTISONE
Active strength .5 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-2010-2 Hydrocortisone 1 in 1 CARTON CREAM 1 4 51672-2010-2 Hydrocortisone 28.4 g in 1 TUBE CREAM 28.4 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 paraffin INACTIVE INGREDIENT I9O0E3H2ZE HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 sodium cetostearyl sulfate INACTIVE INGREDIENT 7ZBS06BH4B HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2010 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241222_2ada9ec2-1c28-4da2-8639-07b3193ffb32.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 147 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BLUE SPRING Foot and Leg Comfort MENTHOL ACA MANAGEMENT LLC 5f52218d-eea4-4640-b820-84c077ab98ba 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 Warnings Exact identifier application number: M017 INTIMALE Benzocaine Delay Gel BENZOCAINE SKINS SEXUAL HEALTH LIMITED b845bfd5-ab73-495f-97ef-e959bc6311d9 2023-11-06 Warnings Exact identifier application number: M017 RAPID PAIN-RELIEF TOPICAL LIDOCAINE HYDROCHLORIDE, MENTHOL NORDIC HEALTHY LIVING INC. a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870 2023-11-06 Warnings Exact identifier application number: M017 PURE PERSONAL All Natural Pain Relief Cream MENTHOL PURE PERSONAL CARE, LLC 8f3fb1d0-d238-4b4c-9816-7e335258d71d 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC 89c80a8f-227d-4ec0-9327-683892e73b6a 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-2010-2 51672201002 1 TUBE in 1 CARTON (51672-2010-2) / 28.4 g in 1 TUBE 1 tube 2001-09-13 0000-00-00 No No Current