FDA.reportPublic FDA data

NDC 51672-2018-02 - Hydrocortisone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-2018
Requested NDC
51672-2018-02
Package NDCs from labels
51672-2018-2, 51672-2018-02
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HydrocortisoneSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-05-27HUMAN OTC DRUG LABEL
Hydrocortisone - Proficient Rx LPProficient Rx LP2024-02-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2018-2Hydrocortisone28.4 g in 1 TUBEOINTMENT28.44
51672-2018-2Hydrocortisone1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2018HYDROCORTISONE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20250529_f7aecfb4-c194-4554-8d05-4e46005e654b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2018-2GM - Gram51672-201803dc5b95-8638-4abc-87f5-eaea1c57114812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
Medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UHYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
Medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UHYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE OINTMENT [PROFICIENT RX LP]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1

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 3 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
unii: WI4X0X7BPJ
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
unii: WI4X0X7BPJ
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.