FDA.reportPublic FDA data

A and D Original

Product NDC
11523-0096
11-digit product format
115230096
Labeler code
11523
Product ID
11523-0096_efa2323c-3fa1-0529-e053-2a95a90ad101
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin and Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-25
Marketing end
0000-00-00
Substance
LANOLIN; PETROLATUM
Active strength
136 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-0096IInactivated by FDA2026-07-31
excluded productproduct11523-0096IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-1IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-2IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-4IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-5IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-6IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-3IInactivated by FDA2026-07-31
excluded packagepackage11523-009611523-0096-7DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
BURTS BEES BABY BEE DIAPER RASHZINC OXIDEBURT'S BEES, INC.168b31b1-9260-61f8-e054-00144ff8d46c2018-12-21WarningsExact identifier
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
BALMEX ADULT CARE RASHZINC OXIDERandob Labs,Ltd.9443a987-c7b2-4b0d-a9dc-02233135af812018-11-13WarningsExact identifier
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
CVS Health Diaper RashZINC OXIDECVS Health12f786a0-0960-4b98-9f0b-dcf3725a98662017-03-20WarningsExact identifier
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0096-32026-01-29C16284748780-149896155-abbe-586f-e063-e6dba90add90A+D ® Prevent Original Ointment
11523-0096-72026-01-29C16284748780-149896155-abbe-586f-e063-e6dba90add90A+D ® Prevent Original Ointment
11523-0096-12025-01-30C16284748780-12cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-22025-01-30C16284748780-12cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-42025-01-30C16284748780-12cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-52025-01-30C16284748780-12cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-62025-01-30C16284748780-12cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0096-3A and D Original454 g in 1 JAROINTMENT45415
11523-0096-7A and D Original340 g in 1 JAROINTMENT34015
11523-0096-1A and D Original1 in 1 CARTONOINTMENT114
11523-0096-1A and D Original42.5 g in 1 TUBEOINTMENT42.514
11523-0096-2A and D Original1 in 1 CARTONOINTMENT114
11523-0096-2A and D Original113 g in 1 TUBEOINTMENT11314
11523-0096-4A and D Original85 g in 1 TUBEOINTMENT8514
11523-0096-4A and D Original1 in 1 CARTONOINTMENT114
11523-0096-5A and D Original14 g in 1 TUBEOINTMENT1414
11523-0096-5A and D Original1 in 1 CARTONOINTMENT114
11523-0096-6A and D Original113 g in 1 TUBEOINTMENT11314
11523-0096-6A and D Original4 in 1 CARTONOINTMENT414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0096-1GM - Gram11523-00968844a8d8-6a7a-4167-844e-d7b9de8303bc12012-07-24
11523-0096-2GM - Gram11523-009663218345-2071-4298-8f67-e637a1c0672512012-07-24
11523-0096-3GM - Gram11523-00960b55e382-bb2a-45e6-b107-e012884ac3ce12018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6HA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
PETROLATUMACTIVE INGREDIENT4T6H12BN9UA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
LANOLINACTIVE MOIETY7EV65EAW6HA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
PETROLATUMACTIVE MOIETY4T6H12BN9UA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]4
LANOLINACTIVE INGREDIENT7EV65EAW6HA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
LANOLINACTIVE MOIETY7EV65EAW6HA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEA AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0096A AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC.]15Legacy NDC, 2 package rows20241208_13abe949-c5ba-4610-8cc2-ac9d2eb32520.zip
11523-0096A AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC.]14Legacy NDC, 10 package rows20231012_aceb23f8-a431-415c-aefd-97047e1aac03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705895A+D Original 15.5 % / 53.4 % Topical OintmentPSN13abe949-c5ba-4610-8cc2-ac9d2eb3252015
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN13abe949-c5ba-4610-8cc2-ac9d2eb3252015
705895lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment [A+D Original]SBD13abe949-c5ba-4610-8cc2-ac9d2eb3252015
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD13abe949-c5ba-4610-8cc2-ac9d2eb3252015
705895A+D Original (lanolin 15.5 % / petrolatum 53.4 % ) Topical OintmentSY13abe949-c5ba-4610-8cc2-ac9d2eb3252015
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY13abe949-c5ba-4610-8cc2-ac9d2eb3252015
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY13abe949-c5ba-4610-8cc2-ac9d2eb3252015
705895A+D Original 15.5 % / 53.4 % Topical OintmentPSNaceb23f8-a431-415c-aefd-97047e1aac0314
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSNaceb23f8-a431-415c-aefd-97047e1aac0314
705895lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment [A+D Original]SBDaceb23f8-a431-415c-aefd-97047e1aac0314
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCDaceb23f8-a431-415c-aefd-97047e1aac0314
705895A+D Original (lanolin 15.5 % / petrolatum 53.4 % ) Topical OintmentSYaceb23f8-a431-415c-aefd-97047e1aac0314
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSYaceb23f8-a431-415c-aefd-97047e1aac0314
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSYaceb23f8-a431-415c-aefd-97047e1aac0314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0096-1115230096011 TUBE in 1 CARTON (11523-0096-1) > 42.5 g in 1 TUBE1 tube2003-06-040000-00-00NoNoCurrent
11523-0096-2115230096021 TUBE in 1 CARTON (11523-0096-2) > 113 g in 1 TUBE1 tube2004-06-040000-00-00NoNoCurrent
11523-0096-311523009603454 g in 1 JAR (11523-0096-3) 454 g2009-12-250000-00-00NoNoCurrent
11523-0096-4115230096041 TUBE in 1 CARTON (11523-0096-4) > 85 g in 1 TUBE1 tube2003-06-040000-00-00NoNoCurrent
11523-0096-5115230096051 TUBE in 1 CARTON (11523-0096-5) > 14 g in 1 TUBE1 tube2021-04-220000-00-00NoNoCurrent
11523-0096-6115230096064 TUBE in 1 CARTON (11523-0096-6) > 113 g in 1 TUBE4 tube2021-05-010000-00-00NoNoCurrent
11523-0096-711523009607340 g in 1 JAR (11523-0096-7) 340 g2009-12-250000-00-00NoNoCurrent