Gene 16 Whitening Factor

Product NDC
69764-001
11-digit product format
697640001
Labeler code
69764
Product ID
69764-001_292b677d-cbe2-4962-9406-123e272e54ea
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
TABLET, SOLUBLE
Route
TOPICAL
Labeler
Shanghai Liangliang Bio Technology Co., Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-25
Substance
ALLANTOIN
Active strength
.5 mg/100mg
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 productproduct69764-001IInactivated by FDA2026-09-09
excluded packagepackage69764-00169764-001-10IInactivated by FDA2026-09-09

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69764-001-10IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69764-001-10IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69764-001-10IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69764-001-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69764-001-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69764-001-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69764-001-10Gene 16 Whitening Factor1 in 1 PACKAGETABLET, SOLUBLE133037
69764-001-10Gene 16 Whitening Factor7 mg in 1 POUCHTABLET, SOLUBLE733037

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
ALLANTOINACTIVE MOIETY344S277G0ZGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
ARBUTININACTIVE INGREDIENTC5INA23HXFGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
ASTAXANTHININACTIVE INGREDIENT8XPW32PR7IGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1UGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
CERAMIDE 3INACTIVE INGREDIENT4370DF050BGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
MANNITOLINACTIVE INGREDIENT3OWL53L36AGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
PUNICA GRANATUM WHOLEINACTIVE INGREDIENTO2ZTS50U5EGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
RESVERATROLINACTIVE INGREDIENTQ369O8926LGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133
TREHALOSEINACTIVE INGREDIENTB8WCK70T7IGENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]3133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69764-001GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]32931Current NDC, Legacy NDC, 2 package rows20241220_b0a99964-d906-4c1d-8256-8c18dd9f88a6.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 1 of 70 · 1,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69764-001-10697640001101 POUCH in 1 PACKAGE (69764-001-10) / 7 mg in 1 POUCH1 pouch2014-09-250000-00-00NoNoCurrent