FDA.reportPublic FDA data

A and D Original

Product NDC
11523-0096
Requested package NDC
11523-0096-2
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#

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-009611523-0096-2IInactivated by FDA2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
11523-0096-32026-01-2949896155-abbe-586f-e063-e6dba90add90A+D ® Prevent Original Ointment
11523-0096-72026-01-2949896155-abbe-586f-e063-e6dba90add90A+D ® Prevent Original Ointment
11523-0096-12025-01-302cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-22025-01-302cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-42025-01-302cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-52025-01-302cef2736-a2d5-d83d-e063-dadaa90ab31fA+D ® Original Ointment
11523-0096-62025-01-302cef2736-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
11523-0096-2115230096021 TUBE in 1 CARTON (11523-0096-2) > 113 g in 1 TUBE1 tube2004-06-040000-00-00NoNoCurrent