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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediadermics eczema 3	COLLOIDAL OATMEAL, DIMETHICONE	Renu Laboratories, LLC	af861f0b-4387-6861-e053-2995a90a8bfa	2025-12-02	Warnings	Exact identifier application number: M016
Flexitol Face and Eyelid Eczema	OATMEAL	LaCorium Health USA Inc.	f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65	2025-12-02	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 41%	Twin Med LLC	3d36e664-ac10-72eb-e063-6294a90a49c4	2025-12-01	Warnings	Exact identifier application number: M016
ProCure Vitamin A and D	WHITE PETROLATUM 93.4%	Twin Med LLC	3d385a07-2a12-fce7-e063-6294a90a32d6	2025-12-01	Warnings	Exact identifier application number: M016
ESTRIOL	ESTRIOL	Shenzhen Mengyue Technology Co., Ltd.	44de9eb4-080e-bfbc-e063-6394a90ac0ea	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Petroleum Jelly	PETROLATUM	New World Imports, Inc	e13fea4e-bd6d-425a-aa7e-1d41dc36bf00	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Cocoa Butter Petroleum Jelly	PETROLATUM	New World Imports, Inc	9358b8ef-df14-45fc-9bfd-9052577a1f88	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Zinc Oxide	ZINC OXIDE	New World Imports Inc	aa9ae4d1-4229-4894-9eaf-8588b2867472	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Petroleum	PETROLATUM	New World Imports, Inc	47e999de-08bd-4121-b6d0-270cc603b56d	2025-12-01	Warnings	Exact identifier application number: M016
HOEGOA Growth Hair Serum	GLYCERIN	Shantou Oralhoe Biotechnology Co., Ltd.	44b6609f-c58b-b6ac-e063-6394a90a749b	2025-11-29	Warnings	Exact identifier application number: M016
OUHOE Micro Darts Tag gone Patch	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	33ce447c-facd-35fb-e063-6394a90a1ead	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Herbal Hair Oil	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	30c3df30-e0c6-4efa-e063-6294a90ac40a	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Aloe Soothing Sun Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	326781e0-55dc-80fc-e063-6394a90a09aa	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Ultra Anti-Acne Control Gel	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3bd1b734-76b0-5264-e063-6294a90a32d0	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Lipoma Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3cb4aed1-3b13-a62a-e063-6294a90a6c39	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Para Crescimento	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	42fbfcac-29ab-51f7-e063-6394a90a626f	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Biotin With Hydrolyzed Collagen	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	43138915-5fe1-6e32-e063-6294a90abefa	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Pain Relief Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3f835843-eb04-6273-e063-6294a90ab2f0	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Skin Tag Remover	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	32922508-74ae-8347-e063-6294a90a6154	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Bodyacne Removal Cleanser	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3bbebf1d-2e22-1427-e063-6294a90a7999	2025-11-27	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