FDA.reportPublic FDA data

A and D

Product NDC
11523-1314
Requested package NDC
11523-1314-3
11-digit product format
115231314
Labeler code
11523
Product ID
11523-1314_ebf1cb62-517f-704f-e053-2a95a90a0ccf
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-25
Marketing end
0000-00-00
Substance
DIMETHICONE; ZINC OXIDE
Active strength
11 mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
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 packagepackage11523-131411523-1314-3IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11523-1314-12023-09-08A+D Diaper Rash Cream
11523-1314-22023-09-08A+D Diaper Rash Cream
11523-1314-32023-09-08A+D Diaper Rash Cream
11523-1314-12023-07-28A+D Diaper Rash Cream
11523-1314-22023-07-28A+D Diaper Rash Cream
11523-1314-32023-07-28A+D Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1314-1A and D42.5 g in 1 TUBECREAM42.59
11523-1314-1A and D1 in 1 CARTONCREAM19
11523-1314-2A and D113 g in 1 TUBECREAM1139
11523-1314-2A and D1 in 1 CARTONCREAM19
11523-1314-3A and D85 g in 1 TUBECREAM859
11523-1314-3A and D1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1314-1GM - Gram11523-1314b5a415c6-40eb-4f2d-b8e9-7354bf8bc83512012-07-24
11523-1314-2GM - Gram11523-1314d8c48e37-cb0a-44b9-a9b3-ef32bdae18a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1OA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
DimethiconeACTIVE MOIETY92RU3N3Y1OA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Aloe Vera FlowerINACTIVE INGREDIENT575DY8C1ERA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Benzyl alcoholINACTIVE INGREDIENTLKG8494WBHA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Coconut oilINACTIVE INGREDIENTQ9L0O73W7LA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Cod liver oilINACTIVE INGREDIENTBBL281NWFGA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Glyceryl MonooleateINACTIVE INGREDIENT4PC054V79PA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Light mineral oilINACTIVE INGREDIENTN6K5787QVPA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3A AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RA AND D (DIMETHICONE AND ZINC OXIDE) CREAM [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1314A AND D (DIMETHICONE AND ZINC OXIDE) CREAM [BAYER HEALTHCARE LLC.]9Legacy NDC, 6 package rows20241208_297e62e4-5282-4733-b3f7-f63a16e8ddee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117243A+D Diaper Rash 1 % / 10 % Topical CreamPSN297e62e4-5282-4733-b3f7-f63a16e8ddee9
686403dimethicone 1 % / zinc oxide 10 % Topical CreamPSN297e62e4-5282-4733-b3f7-f63a16e8ddee9
1117243dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical Cream [A+D Diaper Rash]SBD297e62e4-5282-4733-b3f7-f63a16e8ddee9
686403dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical CreamSCD297e62e4-5282-4733-b3f7-f63a16e8ddee9
1117243A+D Diaper Rash (dimethicone 1 % / zinc oxide 10 % ) Topical CreamSY297e62e4-5282-4733-b3f7-f63a16e8ddee9
686403dimethicone 1 % / zinc oxide 10 % Topical CreamSY297e62e4-5282-4733-b3f7-f63a16e8ddee9
686403dimethicone 10 MG/ML / ZNO 100 MG/ML Topical CreamSY297e62e4-5282-4733-b3f7-f63a16e8ddee9
1117243dimethicone 10 MG/ML / ZNO 100 MG/ML Topical Cream [A+D Diaper Rash]SY297e62e4-5282-4733-b3f7-f63a16e8ddee9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-1314-3115231314031 TUBE in 1 CARTON (11523-1314-3) > 85 g in 1 TUBE1 tube2009-12-250000-00-00NoNoCurrent