FDA.reportPublic FDA data

NDC 71927-018-01 - MEDI-FIRST

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
71927-018
Requested NDC
71927-018-01
Package NDCs from labels
71927-018-01, 71927-018-02, 71927-018-03, 71927-018-04
Manufacturer
Orazen Inc
Effective date
2023-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MEDI-FIRST - Orazen IncOrazen Inc2023-02-17HUMAN OTC DRUG LABEL
MEDI-FIRST - Orazen IncOrazen Inc2023-02-17HUMAN OTC DRUG LABEL
MEDI-FIRST - Orazen IncOrazen Inc2023-02-17HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-018-022025-01-30C16284748780-12cef2736-9966-d83d-e063-dadaa90ab31fMEDI-FIRST Hydrocortisone Cream 1%
71927-018-032025-01-30C16284748780-12cef2736-b175-d83d-e063-dadaa90ab31fMEDI-FIRST Hydrocortisone Cream 1%
71927-018-042025-01-30C16284748780-12cef2736-8c78-d83d-e063-dadaa90ab31fMEDI-FIRST PLUS Hydrocortisone Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-018-01MEDI-FIRST0.9 g in 1 POUCHCREAM0.91
71927-018-01MEDI-FIRST0.9 g in 1 POUCHCREAM0.91
71927-018-01MEDI-FIRST0.9 g in 1 POUCHCREAM0.91
71927-018-02MEDI-FIRST25 in 1 BOXCREAM251
71927-018-03MEDI-FIRST144 in 1 BOXCREAM1441
71927-018-04MEDI-FIRST25 in 1 BOXCREAM251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-018MEDI-FIRST (HYDROCORTISONE ACETATE) CREAM [ORAZEN INC]12 package rows20230219_f4e64bc7-f316-a03d-e053-2a95a90a76a1.zip
71927-018MEDI-FIRST (HYDROCORTISONE ACETATE) CREAM [ORAZEN INC]12 package rows20230219_f4e7135e-042e-9862-e053-2a95a90aec08.zip
71927-018MEDI-FIRST (HYDROCORTISONE ACETATE) CREAM [ORAZEN INC]12 package rows20230219_f4e72b2e-ff27-9870-e053-2995a90a273e.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 7 of 67 · 1,331 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
CVS Healing Balm Skin ProtectantPETROLATUMCVSdf711f93-71bd-4fbe-835c-50eaa9c15e072026-06-15WarningsExact identifier
unii: 4T6H12BN9U
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
rxcui: 106258
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
unii: 4T6H12BN9U
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
rxcui: 106258
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
unii: 4T6H12BN9U
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
rxcui: 106258
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
unii: 4T6H12BN9U
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
unii: 4T6H12BN9U
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.d4d85400-3bb3-11e5-830e-0002a5d5c51b2026-05-29Adverse reactionsExact identifier
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.b955de80-3bb5-11e5-ac7f-0002a5d5c51b2026-05-29Adverse reactionsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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