FDA.reportPublic FDA data

Diaper Rash skin protectant

Product NDC
52000-073
11-digit product format
520000073
Labeler code
52000
Product ID
52000-073_1919f3c5-4277-43c0-bb4e-65577654f8f3
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin and Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Universal Distribution Centre LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-25
Substance
LANOLIN; PETROLATUM
Active strength
136.4; 469.9 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 productproduct52000-073IInactivated by FDA2026-10-16
excluded packagepackage52000-07352000-073-02IInactivated by FDA2026-10-16

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 · 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 packagepackage52000-073-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-073-02f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Diaper Rash skin protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN136.4 mg/g
PETROLATUM469.9 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7EV65EAW6HInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1852246a-6a1c-49ab-e063-6294a90a9048Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-073-022025-07-29C16284748780-13b156c62-2606-fb37-e063-e6dba90a4e07Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-073-01Diaper Rash skin protectant35.4 g in 1 TUBEOINTMENT35.44
52000-073-02Diaper Rash skin protectant1 in 1 CARTONOINTMENT14
52000-073-03Diaper Rash skin protectant1 in 1 CARTONOINTMENT13
52000-073-04Diaper Rash skin protectant35.4 g in 1 TUBEOINTMENT35.43
52000-073-05Diaper Rash skin protectant35.4 g in 1 TUBEOINTMENT35.42
52000-073-06Diaper Rash skin protectant1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-073DIAPER RASH SKIN PROTECTANT (LANOLIN AND PETROLATUM) OINTMENT [UNIVERSAL DISTRIBUTION CENTRE LLC]4Current NDC, Legacy NDC, 2 package rows20241212_b9bbc5ac-18a9-99ec-e053-2995a90a9a76.zip
52000-073DIAPER RASH SKIN PROTECTANT (LANOLIN AND PETROLATUM) OINTMENT [UNIVERSAL DISTRIBUTION CENTRE LLC]2Current NDC, Legacy NDC, 2 package rows20241218_1852246a-6a1c-49ab-e063-6294a90a9048.zip
52000-073DIAPER RASH SKIN PROTECTANT (LANOLIN AND PETROLATUM) OINTMENT [UNIVERSAL DISTRIBUTION CENTRE LLC]1Current NDC, Legacy NDC, 2 package rows20241222_29b5475d-6085-cfe6-e063-6294a90a7e74.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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
ndc (product): 52000-073
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Baby Shower BundleZINC OXIDEC.B. Fleet Company, Inc.a289ed3c-3c7a-4eda-bf5e-139203d2e17e2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-073-015200000730135.4 g in 1 TUBE35.4 gHistorical
52000-073-02520000073021 TUBE in 1 CARTON (52000-073-02) > 35.4 g in 1 TUBE (52000-073-01) 1 tube2021-01-250000-00-00NoNoCurrent
52000-073-03520000073031 TUBE in 1 CARTON (52000-073-03) / 35.4 g in 1 TUBE (52000-073-04) 1 tube2021-01-25NoNoCurrent
52000-073-045200000730435.4 g in 1 TUBE35.4 gHistorical
52000-073-055200000730535.4 g in 1 TUBE35.4 gHistorical
52000-073-06520000073061 TUBE in 1 CARTON (52000-073-06) / 35.4 g in 1 TUBE (52000-073-05) 1 tube2021-01-25NoNoCurrent