Gene 16 Whitening Factor

Product NDC
69764-001
Requested package NDC
69764-001-10
11-digit product format
697640001
Labeler code
69764
Product ID
69764-001_b6a08d69-2199-4ede-835d-3aa60e24b6c0
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
TABLET, SOLUBLE
Route
TOPICAL
Labeler
Shanghai Liang Liang International Inc
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-25
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
1 mg/100mg
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 packagepackage69764-00169764-001-10IInactivated 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 · 6 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…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

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]32931Legacy NDC, 2 package rows20241220_b0a99964-d906-4c1d-8256-8c18dd9f88a6.zip

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