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 FDA2026-10-20
excluded packagepackage52000-07352000-073-02IInactivated by FDA2026-10-20

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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact 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