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 9 of 67 · 1,331 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
WELL AT WALGREENS BABY ADVANCED HEALINGPETROLATUMWALGREEN COMPANY75067953-4cd8-4fcb-b7b7-dd0d2200642d2026-05-05WarningsExact identifier
unii: 4T6H12BN9U
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
unii: 4T6H12BN9U
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
unii: 4T6H12BN9U
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
rxcui: 106258
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
rxcui: 106258
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
unii: T5L8T28FGP
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
rxcui: 106258
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
unii: 4T6H12BN9U
Hydrocortisone AcetateHYDROCORTISONE ACETATEAARNA USA INC.4f9709ed-4818-3d3b-e063-6394a90a0d042026-04-16Adverse reactionsExact identifier
unii: 3X7931PO74
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
HYDROCORTISONEHYDROCORTISONE CREAMHART Healthc76fb030-cbb5-4773-aa52-d038cb41d0af2026-04-15WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
rxcui: 106258
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
rxcui: 106258
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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