Zinc Oxide

Product NDC: 69771-109
11-digit product format: 697710109
Labeler code: 69771
Product ID: 69771-109_3ff42319-2fba-acb9-e063-6294a90a4129
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Geri-Gentle Corporation
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-15
Substance: ZINC OXIDE
Active strength: 20 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 18 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
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	69771-109-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69771-109-39	`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	69771-109-38	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69771-109-39	`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	69771-109-38	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69771-109-39	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69771-109-38	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69771-109-39	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69771-109-38	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69771-109-39	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69771-109-38	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69771-109-39	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zinc Oxide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198911	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f5cfab62-8aab-4109-b15b-4fe380f7cb9e	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69771-109-38	2025-01-06	Zinc Oxide
69771-109-39	2025-01-06	Zinc Oxide
69771-109-38	2023-01-30	Zinc Oxide
69771-109-39	2023-01-30	Zinc Oxide
69771-109-38	2020-02-04	Zinc Oxide
69771-109-39	2020-02-04	Zinc Oxide
69771-109-38	2020-01-31	Zinc Oxide
69771-109-39	2020-01-31	Zinc Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69771-109-38	Zinc Oxide	1 in 1 BOX	OINTMENT	1	6
69771-109-38	Zinc Oxide	28.4 g in 1 TUBE	OINTMENT	28.4	6
69771-109-39	Zinc Oxide	1 in 1 BOX	OINTMENT	1	6
69771-109-39	Zinc Oxide	56.8 g in 1 TUBE	OINTMENT	56.8	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69771-109	ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]	5	Current NDC, Legacy NDC, 4 package rows	20250108_f5cfab62-8aab-4109-b15b-4fe380f7cb9e.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 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermaka Infants and Kids Multi Purpose Skin Protectant	ZINC OXIDE	Dermaka Skin Products LLC	f84dfd55-db6c-4d75-be67-4d13a139e209	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose	DIMETHICONE	L'Oreal USA Products Inc	805cd262-2689-4818-8fed-ddefacbdde23	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose	DIMETHICONE	Cosmetique Active Production	d19f482c-bec7-45aa-b22f-fe91a3dc717d	2026-09-10	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	CVS Pharmacy, Inc.	35e67726-4527-4cd7-8e73-30325a32402c	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	CVS Pharmacy, Inc.	606f65a8-08fd-4ab6-9d68-03ddf662bdf0	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Soothing Moisturizing Cream	COLLOIDAL OATMEAL	Nice-Pak Products, LLC	23548524-2e2e-4d1a-9ebb-6f86d6279e93	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walgreen Co.	22bd8e87-965c-466b-bb9b-7d4753e500bc	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. pharmacy Scar Cream	ALLANTOIN	OL PHARMA TECH, LLC Drs PHARMACY	d0381034-8cf7-5e8d-e053-2995a90a9faa	2026-09-09	Warnings	Exact identifier application number: M016
Drs. Pharmacy baby healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	5b14ffa0-9486-a7fe-e063-6394a90ab3ed	2026-09-09	Warnings	Exact identifier application number: M016
Wart Remover	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	5af3afe1-dad5-91b7-e063-6294a90ab95e	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb3595-f014-153e-e063-6294a90ad34b	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb59b4-491c-45bb-e063-6294a90a0ae6	2026-09-08	Warnings	Exact identifier application number: M016
Claravie	ALUMINUM HYDROXIDE GEL	Gentell LLC	5afea757-8feb-f907-e063-6394a90a6259	2026-09-08	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	United Natural Foods, Inc. dba UNFI	242adc68-f9e0-4f69-a580-a107d1634b50	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a9aaca8-474a-0393-e063-6394a90a5a3a	2026-09-04	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	5a7b0470-3ed5-5b92-e063-6294a90ae0f4	2026-09-03	Warnings	Exact identifier application number: M016
First Aid Beauty Face and Body Bestsellers Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a974dbf-84ac-5374-e063-6294a90a8da0	2026-09-03	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	Jell Pharmaceuticals Pvt. Ltd.	cdc297cb-476a-6da9-e053-2a95a90a399a	2026-09-02	Warnings	Exact identifier application number: M016
Nail Treatment Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5a7cd607-a50e-17d0-e063-6294a90acdb2	2026-09-02	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	f5cfab62-8aab-4109-b15b-4fe380f7cb9e	6
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	f5cfab62-8aab-4109-b15b-4fe380f7cb9e	6
198911	zinc oxide 20 % Topical Ointment	SY	f5cfab62-8aab-4109-b15b-4fe380f7cb9e	6
198911	zinc oxide 200 MG per GM Topical Ointment	SY	f5cfab62-8aab-4109-b15b-4fe380f7cb9e	6
198911	ZNO 0.2 MG/MG Topical Ointment	SY	f5cfab62-8aab-4109-b15b-4fe380f7cb9e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69771-109-38	69771010938	1 TUBE in 1 BOX (69771-109-38) / 28.4 g in 1 TUBE	1 tube	2017-01-15	0000-00-00	No	No	Current
69771-109-39	69771010939	1 TUBE in 1 BOX (69771-109-39) / 56.8 g in 1 TUBE	1 tube	2017-01-15	0000-00-00	No	No	Current