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 34 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ODLUMIVIE Salmon DNA Repairing Serum	RH-OLIGOPEPTIDE-1	ODLUMIVIE	435ecb5b-0d12-4da1-e063-6394a90a8be2	2025-11-11	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	KROGER	3feb1346-76b6-fbb6-e063-6394a90a17d1	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Ceramide ReviCell Cream	CERAMIDE NP	ODLUMIVIE	435ee48f-1b9e-6d08-e063-6394a90af5b5	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Dendrobium Restorative Mask	DENDROBIUM OFFICINALE STEM	ODLUMIVIE	435ef0e0-50be-c4e4-e063-6294a90a8e8e	2025-11-11	Warnings	Exact identifier application number: M016
Au Kah Chuen Fugical	CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID	Zhejiang Dingtai Pharmaceutical Co., Ltd	5b4add17-6c3d-4093-826a-2edb41c1d1db	2025-11-10	Warnings	Exact identifier application number: M016
TATWAX VITAMINS AD	PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	333fdce4-5a1d-45a4-94fe-81d47ecd2670	2025-11-07	Warnings	Exact identifier application number: M016
Arme Scar Gel	DIMETHICONE	Nanjing Ludejin Corporation Management Co., Ltd	42e9a59a-480e-f74a-e063-6294a90a0640	2025-11-06	Warnings	Exact identifier application number: M016
Baby Diaper Rash Cream	ZINC OXIDE	Hello Bello	42f14aa6-5694-7727-e063-6294a90a09f3	2025-11-06	Warnings	Exact identifier application number: M016
Atti amour Rose Anti-Aging Repair Classic Essence	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1e874ac0-a993-be9e-e063-6394a90af424	2025-11-06	Warnings	Exact identifier application number: M016
Atti amour Rose Anti-Aging Repair Eye Cream	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eeb9c36-5bd8-ec90-e063-6294a90ae4e1	2025-11-06	Warnings	Exact identifier application number: M016
Atti amour Rose Anti-Aging Repair Serum	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eb08f86-eb2a-7f29-e063-6294a90a0516	2025-11-06	Warnings	Exact identifier application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing Cream	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eec4cfe-d5a3-3570-e063-6294a90ac38b	2025-11-06	Warnings	Exact identifier application number: M016
Spa Dry Heel Foot Relief	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9	2025-11-05	Warnings	Exact identifier application number: M016
Royal Jelly Berry Powerful Lip Care	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	09323fbe-76b5-48c6-80a7-c35b64110a7d	2025-11-05	Warnings	Exact identifier application number: M016
Pink Eczema Cream	COLLOIDAL OATMEAL	MOOGOO SKIN CARE PTY LTD	3b8d92d0-ab7f-8dd5-e063-6394a90aa3af	2025-11-04	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE, PETROLATUM	Medline Industries, LP	f162b1a8-65b3-13a8-e053-2a95a90a3f13	2025-11-04	Warnings	Exact identifier application number: M016
Medline	PETROLATUM	Medline Industries, LP	f3062b61-e4c4-9f57-e053-2995a90aa028	2025-11-04	Warnings	Exact identifier application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented Mask	TITANIUM DIOXIDE	Guangzhou Meijiao Medical Biotechnology Co., Ltd.	3cdf06f2-63f2-7a59-e063-6294a90a72ea	2025-11-03	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Premier Brands of America Inc.	38583c02-497b-922c-e063-6294a90a49de	2025-11-03	Warnings	Exact identifier application number: M016
The Zoeun Omega Serum	COLLOIDAL OATMEAL	Sturgeonbio Co.,Ltd.	4277da80-b55b-74af-e063-6394a90af325	2025-10-31	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