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 firm2026-10-21

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 22 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLCc82f236d-c27f-458c-bcd8-19877d09e9a32026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLC5e83811f-773f-43e7-bab8-f9e558fb0e002026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d76e116f-4b22-4633-8487-17ad3b5778c72026-02-04WarningsExact identifier
application number: M016
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
application number: M016
Daily MoisturizingDIMETHICONECVS Pharmacy, Inc.edc20df4-561e-486f-b9f1-900672a0f2a42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.a153842c-d9ce-4658-912b-362a6f20b0aa2026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
NeurexaCOLLOIDAL OATMEALMETHODIQ INC.494d7915-acad-260e-e063-6394a90a182c2026-02-03WarningsExact identifier
application number: M016
Thera Plus Vitamin A and D CreamDIMETHICONE, ZINC OXIDEFOURSTAR GROUP USA, INC.36f09fa4-a3b8-4104-9745-ee60aa493b062026-02-02WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMKroger Co.b4aa9b58-d95e-4dac-9a34-213482e8ca342026-02-02Warnings, Adverse reactionsExact identifier
application number: M016
Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49e45462-a05f-d370-e063-6394a90a1e0f2026-02-02WarningsExact identifier
application number: M016
Barrier Repair CreamCREAMSteel City Health Private Limited4842f653-7137-eca4-e063-6394a90a8c552026-01-31WarningsExact identifier
application number: M016
Cracked Heel Repair BalmDIMETHICONEDelta Brands Inc.42b7c9f8-0557-8e33-e063-6394a90a59192026-01-30WarningsExact identifier
application number: M016
Readybath TPC Total Perineal CareDIMETHICONEMedline Industries, Inc.43a3f0f7-f76f-434d-a21f-7eaa3638913d2026-01-30WarningsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDERite Aid Corporation3af9f0e5-0d79-4178-b29e-3b60735bf4ce2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact 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