Baby Daily Moisturizing Fragrance Free

Product NDC
63940-433
11-digit product format
639400433
Labeler code
63940
Product ID
63940-433_28b33138-2288-4e8e-aa6e-25f0dc9deffe
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Harmon Stores Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63940-433IInactivated by FDA2026-10-05
excluded packagepackage63940-43363940-433-12IInactivated 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 · 42 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 packagepackage63940-433-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63940-433-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63940-433-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63940-433-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63940-433-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63940-433-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63940-433-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63940-433-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63940-433-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63940-433-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63940-433-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63940-433-12557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63940-433-128af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63940-433-12834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63940-433-121332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63940-433-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63940-433-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63940-433-12bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63940-433-128dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63940-433-12e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63940-433-129bebd1f3094a…5416666fcb17…

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-433-122020-01-31C16284748780-19d75b9d0-4780-f424-e053-dadaa90a57ceBaby Daily Moisturizing Fragrance Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-433-12Baby Daily Moisturizing Fragrance Free227 mL in 1 TUBELOTION2271

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61BABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
OATMEALINACTIVE INGREDIENT8PI54V663YBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-433BABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]1Legacy NDC, 1 package rows20140908_28b33138-2288-4e8e-aa6e-25f0dc9deffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSN28b33138-2288-4e8e-aa6e-25f0dc9deffe1
876980dimethicone 12 MG/ML Topical LotionSCD28b33138-2288-4e8e-aa6e-25f0dc9deffe1
876980dimethicone 1.2 % Topical LotionSY28b33138-2288-4e8e-aa6e-25f0dc9deffe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63940-433-1263940043312227 mL in 1 TUBE227 mlHistorical