FDA.reportPublic FDA data

Aquaphor Original

Product NDC
10356-100
11-digit product format
103560100
Labeler code
10356
Product ID
10356-100_46041c57-79d9-e56c-e063-6394a90a8783
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1975-06-01
Substance
PETROLATUM
Active strength
41 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Aquaphor Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM41 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725145Internal RxNorm lookup
1052954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d38ec874-7b8c-4b9b-92b6-286278bb67f3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-100-37Aquaphor Original396 g in 1 JAROINTMENT39616

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9UAQUAPHOR ORIGINAL (PETROLATUM) OINTMENT [BEIERSDORF INC]2
PetrolatumACTIVE MOIETY4T6H12BN9UAQUAPHOR ORIGINAL (PETROLATUM) OINTMENT [BEIERSDORF INC]2
PetrolatumACTIVE INGREDIENT4T6H12BN9UAQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PetrolatumACTIVE MOIETY4T6H12BN9UAQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
CERESININACTIVE INGREDIENTQ1LS2UJO3AAQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEAQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPAQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10356-100AQUAPHOR ORIGINAL (PETROLATUM) OINTMENT [BEIERSDORF INC]15Current NDC, Legacy NDC, 1 package rows20250101_d38ec874-7b8c-4b9b-92b6-286278bb67f3.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052954Aquaphor 41 % Topical OintmentPSNd38ec874-7b8c-4b9b-92b6-286278bb67f316
725145petrolatum 41 % Topical OintmentPSNd38ec874-7b8c-4b9b-92b6-286278bb67f316
1052954petrolatum 0.41 MG/MG Topical Ointment [Aquaphor]SBDd38ec874-7b8c-4b9b-92b6-286278bb67f316
725145petrolatum 0.41 MG/MG Topical OintmentSCDd38ec874-7b8c-4b9b-92b6-286278bb67f316
1052954Aquaphor 0.41 MG/MG Topical OintmentSYd38ec874-7b8c-4b9b-92b6-286278bb67f316
1052954Aquaphor 41 % Topical OintmentSYd38ec874-7b8c-4b9b-92b6-286278bb67f316
725145petrolatum 41 % Topical OintmentSYd38ec874-7b8c-4b9b-92b6-286278bb67f316
1052954Aquaphor 41 % Topical OintmentPSNdddcbb2e-7ade-4b05-bf19-229946e1ac261
725145petrolatum 41 % Topical OintmentPSNdddcbb2e-7ade-4b05-bf19-229946e1ac261
1052954petrolatum 0.41 MG/MG Topical Ointment [Aquaphor]SBDdddcbb2e-7ade-4b05-bf19-229946e1ac261
725145petrolatum 0.41 MG/MG Topical OintmentSCDdddcbb2e-7ade-4b05-bf19-229946e1ac261
1052954Aquaphor 0.41 MG/MG Topical OintmentSYdddcbb2e-7ade-4b05-bf19-229946e1ac261
1052954Aquaphor 41 % Topical OintmentSYdddcbb2e-7ade-4b05-bf19-229946e1ac261
725145petrolatum 41 % Topical OintmentSYdddcbb2e-7ade-4b05-bf19-229946e1ac261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10356-100-3710356010037396 g in 1 JAR (10356-100-37) 396 g1975-06-010000-00-00NoNoCurrent