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…`

Reported adverse events (FAERS/openFDA)#

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

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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Copperlife Foot	DIMETHICONE 1%	Tommie Copper, Inc.	cb825d2c-6333-3c1f-e053-2995a90a78f3	2024-12-15	Warnings	Exact identifier application number: M016
Tommie Copper Foot	DIMETHICONE 1%	Tommie Copper, Inc.	ca3d3374-a3d4-69e5-e053-2995a90a3ece	2024-12-15	Warnings	Exact identifier application number: M016
Evereden Healing Eczema Treatment	COLLOIDAL OATMEAL	Eden Brands, Inc.	d43f0eaa-aab0-eaff-e053-2995a90ac5c8	2024-12-13	Warnings	Exact identifier application number: M016
Babo Fragrance Free Diaper Cream	ZINC OXIDE	Babo Botanicals, Inc.	adcd4fc7-c400-fc8e-e053-2a95a90a7e1f	2024-12-12	Warnings	Exact identifier application number: M016
Domeboro	ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE	Advantice Health, LLC.	28c39200-2f7c-954b-3ce7-7349b2738812	2024-12-12	Warnings	Exact identifier application number: M016
Atopis Eczema Therapy Cream	COLLOIDAL OATMEAL	Bionona Limited	8d4b4a14-b631-f2fa-e053-2a95a90a932f	2024-12-12	Warnings	Exact identifier application number: M016
Desitin Daily Defense Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	b6e0d1a3-e469-4102-916b-d5cc8ca12e73	2024-12-11	Warnings	Exact identifier application number: M016
Little Me Multipurpose Baby Balm	WHITE PETROLATUM	Shalom International Corp	e09518f1-3691-4d85-a8e1-a5c452057066	2024-12-11	Warnings	Exact identifier application number: M016
Blistex Ivarest Poison Ivy Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Blistex Inc.	e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a	2024-12-11	Warnings	Exact identifier application number: M016
Deep Renewal Broad Spectrum	DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE	Blistex Inc	11c0e084-dc40-4969-a176-3af4116d6f27	2024-12-10	Warnings	Exact identifier application number: M016
BOA VIDA Recovery Creme	DIMETHICONE	Central Solutions Inc	bfa07058-7a20-4b9f-bad1-4b9fb5c037e0	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Canopy	DIMETHICONE	Central Solutions Inc	44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf	2024-12-09	Warnings	Exact identifier application number: M016
DermaCen Skin Protectant	ZINC OXIDE	Central Solutions Inc	990c3a65-bca5-1f0d-e053-2995a90aa7ae	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Calvida	ZINC OXIDE	Central Solutions Inc	48eb2031-bc80-45d5-b8b3-cc08fcab64f1	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Cleansing	DIMETHICONE	Central Solutions Inc	0b456b20-ab06-4adf-b5f0-1693d33979df	2024-12-09	Warnings	Exact identifier application number: M016
SOOTHE Sensitive Skin Treatment	ALLANTOIN, DIMETHICONE	Rodan & Fields	2bd8cac4-5f40-4d04-91f2-3ea8a138033b	2024-12-09	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment	COLLOIDAL OATMEAL	Kenvue Brands LLC	f67e528a-b822-3f7a-e053-2995a90ae733	2024-12-06	Warnings	Exact identifier application number: M016
Humphreys Maravilla	WITCH HAZEL	Humphreys Pharmacal, Incorporated	7d403bf4-8a0d-4337-8e81-1149cd0ae1dc	2024-12-06	Warnings	Exact identifier application number: M016
Skin Soothing Cream	COLLOIDAL OATMEAL	Allure Labs Inc	9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3	2024-12-05	Warnings	Exact identifier application number: M016
Skin Soothing Cream - Nut Free	COLLOIDAL OATMEAL	Allure Labs	b5eb48a5-e884-3bf6-e053-2a95a90abb97	2024-12-05	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