GMC Medical

Product NDC: 64127-134
11-digit product format: 641270134
Labeler code: 64127
Product ID: 64127-134_3d692071-b45c-44b8-bf53-99de505b036d
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide and octinoxate
Dosage form: CREAM
Route: TOPICAL
Labeler: Laboratoires dermo Cosmetik Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-02-10
Marketing end: 0000-00-00
Substance: ZINC OXIDE; OCTINOXATE
Active strength: 12 mg/100mL; mg/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64127-134		D	Discontinued by firm	2026-10-05
excluded package	package	64127-134	64127-134-01	D	Discontinued by firm	2026-10-05
excluded package	package	64127-134	64127-134-02	D	Discontinued by firm	2026-10-05
excluded package	package	64127-134	64127-134-03	D	Discontinued by firm	2026-10-05

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64127-134-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64127-134-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64127-134-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64127-134-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64127-134-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64127-134-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64127-134-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64127-134-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64127-134-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64127-134-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64127-134-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64127-134-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64127-134-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64127-134-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64127-134-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64127-134-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64127-134-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64127-134-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64127-134-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64127-134-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64127-134-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64127-134-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64127-134-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64127-134-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64127-134-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64127-134-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64127-134-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64127-134-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64127-134-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64127-134-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64127-134-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64127-134-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64127-134-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64127-134-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64127-134-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64127-134-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64127-134-01	GMC Medical	50 mL in 1 TUBE	CREAM	50 mL	8.3 mg in 100mL	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
zinc oxide	ACTIVE INGREDIENT	SOI2LOH54Z	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
octinoxate	ACTIVE MOIETY	4Y5P7MUD51	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
zinc oxide	ACTIVE MOIETY	SOI2LOH54Z	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
HECTORITE	INACTIVE INGREDIENT	08X4KI73EZ	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
POLYGLYCERYL-10 DECAOLEATE	INACTIVE INGREDIENT	NJR3XZA3NW	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
POLYGONUM AVICULARE TOP	INACTIVE INGREDIENT	ZCD6009IUF	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
PPG-3 MYRISTYL ETHER	INACTIVE INGREDIENT	7913J43WZ5	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
SENNA ALATA LEAF	INACTIVE INGREDIENT	4BXR6YZN92	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64127-134	GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]	1	Legacy NDC	20140210_104e5e32-7b73-41e6-b40a-41fe5556c036.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64127-134-01	64127013401	50 mL in 1 TUBE	50 ml	Historical