A and D

Product NDC
0404-0375
Requested package NDC
0404-0375-47
11-digit product format
004040375
Labeler code
0404
Product ID
0404-0375_f1628c66-5650-fa92-e053-2995a90a601f
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Henry Schein, Inc.
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-04
Marketing end
2024-09-01
Substance
PETROLATUM
Active strength
938 mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0404-03750404-0375-47DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6
PETROLATUMACTIVE MOIETY4T6H12BN9UA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6
CORN OILINACTIVE INGREDIENT8470G57WFMA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6
ERGOCALCIFEROLINACTIVE INGREDIENTVS041H42XCA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCA AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]6

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 57 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
application number: M016
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
application number: M016
Attitude Diaper Cream Zinc UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)00283894-ddc6-0faa-e063-6394a90ae47c2024-10-02WarningsExact identifier
application number: M016
DermacinRx Zinc Oxide Skin HealingZINC OXIDEPureTek Corporation541b8da8-f0c1-4f57-94a7-193084d9a6112024-10-02WarningsExact identifier
application number: M016
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
application number: M016
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
application number: M016
Barrier Build Skin Protectant CreamCOLLOIDAL OATMEALILIA, Inc.231d41b8-2a56-6eb8-e063-6394a90ac64f2024-09-27WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.229ee3a7-4129-7b59-e063-6394a90a6f402024-09-23WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0375-4700404037547144 PACKET in 1 CARTON (0404-0375-47) > 5 g in 1 PACKET (0404-0375-05) 144 packet2011-12-042024-09-01NoNoCurrent