A and D

Product NDC
0404-0375
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0404-0375DDiscontinued by firm2026-10-16
excluded packagepackage0404-03750404-0375-47DDiscontinued by firm2026-10-16

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0404-0375-47d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0404-0375-47f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0404-0375-472ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0404-0375-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0404-0375-47cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0404-0375-47cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0404-0375-47302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0404-0375-47ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0404-0375-470efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0404-0375-47ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0404-0375-47367a005e9d99…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 42 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
application number: M016
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
application number: M016
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
application number: M016
BabyDiaperCreamBABY DIAPER CREAMWhole Foods Marketd7b19529-d0b2-638b-e053-2a95a90acf2f2025-04-29WarningsExact identifier
application number: M016
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
application number: M016
Assurance Barrier CreamDIMETHICONE CREAMWalmart Inc23a2a04f-71ce-4fa1-e063-6394a90a649e2025-04-22WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC21d2c0a0-70c3-7fd3-e063-6394a90a46d42025-04-18WarningsExact identifier
application number: M016
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
application number: M016
Firming Care GelFIRMING CARE GELGuangzhou Jiaan Cosmetics Co.,Ltd.32cb8a71-81cd-cdbd-e063-6394a90ac07f2025-04-15WarningsExact identifier
application number: M016
Baby Mantra Diaper CreamZINC OXIDE 10%Renu Laboratories, LLC0427bbc9-f4c0-0eb6-e063-6294a90a71992025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELTOP CARE (Topco Associates LLC)23b592f7-3af3-45ef-897a-fe33ab518b6d2025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELStrategic Sourcing Services LLCef3408db-de98-4a43-9215-f80fed14815c2025-04-14WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
application number: M016
4% 10gTATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD322daa32-a74e-1fee-e063-6294a90a37aa2025-04-07WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINAsclemed USA, Inc.60656ca1-5218-4595-854e-19f1061def1e2025-04-01WarningsExact identifier
application number: M016
Dr. Maxs DiaperZINC OXIDEDr. Maxs LLC31bfa962-5e3b-c5d2-e063-6294a90ac1772025-04-01WarningsExact identifier
application number: M016
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
application number: M016
4% TATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD31646815-f591-c560-e063-6294a90ad11a2025-03-28WarningsExact identifier
application number: M016
Face Saver GelSKIN PROTECTANT GELNeat Feat Products Limited31563dd7-9f58-80f6-e063-6294a90a55712025-03-27WarningsExact identifier
application number: M016
PorphoseCOLLOIDAL OATMEAL TOPICAL SPRAYPorphose315951e0-899f-c968-e063-6294a90abe612025-03-27WarningsExact 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 packet2011-12-040000-00-00NoNoCurrent