FDA.reportPublic FDA data

NDC 51672-2013-01 - Hydrocortisone with Aloe

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
51672-2013
Requested NDC
51672-2013-01
Package NDCs from labels
51672-2013-1, 51672-2013-2, 51672-2013-3, 51672-2013-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone 1% with AloeSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-03HUMAN OTC DRUG LABEL
Hydrocortisone with Aloe - Proficient Rx LPProficient Rx LP2024-02-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2013-1Hydrocortisonewith Aloe14.2 g in 1 TUBECREAM14.25
51672-2013-1Hydrocortisonewith Aloe1 in 1 CARTONCREAM15
51672-2013-2Hydrocortisonewith Aloe1 in 1 CARTONCREAM15
51672-2013-2Hydrocortisonewith Aloe28.4 g in 1 TUBECREAM28.45
51672-2013-3Hydrocortisonewith Aloe60 g in 1 TUBECREAM605
51672-2013-3Hydrocortisonewith Aloe1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2013HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 6 package rows20241222_caa2fd64-e262-4d7c-ad8a-69f506feba8c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2013-1GM - Gram51672-201387032096-3d1b-41ba-b158-a04ffa9cd05012013-03-03
51672-2013-2GM - Gram51672-20139666b4c8-273e-4737-8c31-b2126b89b2ce12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS 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 87 of 192 · 3,839 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
application number: M017
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
application number: M017
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
application number: M017
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy7e9285fd-26d5-3eac-e053-2991aa0ae2db2025-10-29WarningsExact identifier
application number: M017
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
unii: WI4X0X7BPJ
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack8c03671d-28ab-4027-8f5f-d342177ce5f22025-10-28Adverse reactionsExact identifier
unii: WI4X0X7BPJ
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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