Petrolatum

Product NDC
0404-0042
11-digit product format
004040042
Labeler code
0404
Product ID
0404-0042_f1628b72-eb7b-1590-e053-2a95a90ad4e9
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
2011-04-05
Marketing end
2025-04-01
Substance
PETROLATUM
Active strength
1 g/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 productproduct0404-0042DDiscontinued by firm2026-10-15
excluded packagepackage0404-00420404-0042-47DDiscontinued by firm2026-10-15

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 · 4 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 packagepackage0404-0042-47d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0404-0042-47f5e01cc5f278…a2eaf40c39c3…

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 INGREDIENT4T6H12BN9UPETROLATUM OINTMENT [HENRY SCHEIN, INC.]5
PETROLATUMACTIVE MOIETY4T6H12BN9UPETROLATUM OINTMENT [HENRY SCHEIN, INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPETROLATUM OINTMENT [HENRY SCHEIN, INC.]5

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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
application number: M016
DE LA CRUZ DIAPER RASHALLANTOIN, PETROLATUM, AND ZINC OXIDEDLC Laboratories, Inc.5949aa0f-a7cb-453c-81fd-9fa24653a4522026-01-07WarningsExact identifier
application number: M016
Thera Wise Natural HemorrhoidalWITCH HAZELDerma Wise Skin Care Ltd.a29fb680-cfc8-4a7b-9970-563fa0e2bed62026-01-06WarningsExact identifier
application number: M016
Sky and Sol SPF25 Lip BalmSKY AND SOL SPF25 LIP BALMGuangzhou Fantesy Biotechnology Co.,Ltd1f37c0c3-6443-60a3-e063-6394a90a596f2026-01-05WarningsExact identifier
application number: M016
Remedy EssentialsWHITE PETROLATUM,ZINC OXIDEMedline Industries, LP42a033d6-782b-2d7f-e054-00144ff8d46c2026-01-05WarningsExact identifier
application number: M016
BUNUSS Estriol FaceESTRIOLJiashen International Trade Limited478b5690-038a-ba1c-e063-6394a90a3ad62026-01-04WarningsExact identifier
application number: M016
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
application number: M016
Puriya Eczema CreamCOLLOIDAL OATMEALIPC Republic, Inc.24ac044e-13fa-5ff6-e063-6294a90a99852026-01-01WarningsExact identifier
application number: M016
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMJC SALES48f74b99-7ead-b0d0-e063-6394a90a49292026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES48f79c2a-b314-169f-e063-6294a90a576e2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES490ac0a6-eac0-a74f-e063-6394a90a84ed2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMJC SALES490af001-c78c-e2d2-e063-6394a90abdb02026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946ac1a-f475-fbb1-e063-6394a90a30bc2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946d1b7-ae1b-1e73-e063-6394a90a1ed22026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49471d77-303a-8536-e063-6394a90aea512026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49472319-09d1-7c4f-e063-6294a90a26a72026-01-01WarningsExact identifier
application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1fa6282a-172e-f5c8-e063-6294a90a4fb12025-12-31WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla LatteCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27713ae6-b428-e0d7-e063-6394a90a7a892025-12-31WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0042-4700404004247144 PACKET in 1 BOX (0404-0042-47) > 5 g in 1 PACKET (0404-0042-05) 144 packet2015-06-080000-00-00NoNoCurrent