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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69764-001		I	Inactivated by FDA		2026-08-17
excluded package	package	69764-001	69764-001-10	I	Inactivated by FDA		2026-08-17

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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69764-001-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69764-001-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69764-001-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69764-001-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69764-001-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69764-001-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2026-01-23	Shanghai Liangliang Bio Technology Co., Ltd
2025-07-29	Shanghai Liangliang Bio Technology Co., Ltd
2024-12-18	Shanghai Liangliang Bio Technology Co., Ltd
2024-07-30	Shanghai Liangliang Bio Technology Co., Ltd
2024-01-30	Shanghai Liangliang Bio Technology Co., Ltd
2023-12-29	Shanghai Liangliang Bio Technology Co., Ltd
2023-07-28	Shanghai Liangliang Bio Technology Co., Ltd
2022-12-22	Shanghai Liangliang Bio Technology Co., Ltd
2022-07-29	Shanghai Liangliang Bio Technology Co., Ltd
2021-12-17	Shanghai Liangliang Bio Technology Co., Ltd
2021-07-23	Shanghai Liangliang Bio Technology Co., Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69764-001-10	Gene 16 Whitening Factor	1 in 1 PACKAGE	TABLET, SOLUBLE	1		33037
69764-001-10	Gene 16 Whitening Factor	7 mg in 1 POUCH	TABLET, SOLUBLE	7		33037

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
ARBUTIN	INACTIVE INGREDIENT	C5INA23HXF	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
ASTAXANTHIN	INACTIVE INGREDIENT	8XPW32PR7I	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
CENTELLA ASIATICA	INACTIVE INGREDIENT	7M867G6T1U	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
PUNICA GRANATUM WHOLE	INACTIVE INGREDIENT	O2ZTS50U5E	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
RESVERATROL	INACTIVE INGREDIENT	Q369O8926L	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	3133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69764-001	GENE 16 WHITENING FACTOR (ALLANTOIN) TABLET, SOLUBLE [SHANGHAI LIANG LIANG INTERNATIONAL INC]	32931	Current NDC, Legacy NDC, 2 package rows	20241220_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 69 · 1,370 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Jelly, Lil Drug Store	PETROLATUM JELLY	Lil' Drug Store Products, Inc.	5862af40-97e2-d792-e063-6394a90a0f1a	2026-08-06	Warnings	Exact identifier application number: M016
AOAO RAPID ACNE RELIEF	SALICYLIC ACID,BENZOYL PEROXIDE	Guangzhou Senmai Biotechnology Co.,Ltd.	586df874-0f71-ed46-e063-6294a90a0a8e	2026-08-06	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	WHITE PETROLATUM	Dealmed Medical Supplies, LLC.	d6584809-b438-4b2c-ab37-522e0dbef470	2026-08-05	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	PETROLATUM	Dealmed Medical Supplies, LLC.	84afe4ae-f9e8-406f-9fbe-f413975f86eb	2026-08-05	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Walgreens	1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5	2026-08-04	Warnings	Exact identifier application number: M016
Nail Treatment Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE	ZINC OXIDE	TWIN MED, LLC	e68ae97e-668e-31c2-e053-2995a90ab4d3	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE VITAMIN A AND D Skin Protectant	PETROLATUM	TWIN MED, LLC	bbbca68e-1b65-49b1-a5fa-ed4da55d05e3	2026-08-03	Warnings	Exact identifier application number: M016
procure	PETROLATUM	TWIN MED, LLC	32520d8f-91ee-47a1-9129-bf0746791f4b	2026-08-03	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 44.28%	Twin Med LLC	3ab7bfb2-bbcf-0822-e063-6294a90af084	2026-08-03	Warnings	Exact identifier application number: M016
456 Acne Relief Cream	NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT	Guangzhou Senmai Biotechnology Co.,Ltd.	5830fd36-0613-1980-e063-6294a90adfb7	2026-08-03	Warnings	Exact identifier application number: M016
Crogooe Skin Relief Cream	COLLOIDAL OATMEAL	Guangdong Outeli Biotechnology Co., Ltd.	57f9b3e8-25d3-2b20-e063-6394a90aaea5	2026-08-01	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	57c3556a-aad3-3e65-e063-6394a90ab689	2026-07-29	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69764-001-10	69764000110	1 POUCH in 1 PACKAGE (69764-001-10) / 7 mg in 1 POUCH	1 pouch	2014-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Shanghai Liangliang Bio Technology Co., Ltd	Shanghai Liangliang Bio Technology Co., Ltd	2026-01-23	HUMAN OTC DRUG LABEL	33037