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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Infection Protection Wound Care	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e98d1d8c-c979-49de-9bd8-cd409efff6de	2025-07-11	Warnings	Exact identifier application number: M016
Neosporin Lip Health Overnight Renewal Therapy	PETROLATUM	Kenvue Brands LLC	0da54fe1-c99f-4a2d-9ee5-2dc24005096c	2025-07-10	Warnings	Exact identifier application number: M016
COCOA BUTTER PETROLEUM jelly	PETROLATUM	Savvy Care & Cosmetics Pvt. Ltd.	397d13f1-3b86-3c76-e063-6394a90a0f24	2025-07-09	Warnings	Exact identifier application number: M016
Pipette Eczema	COLLOIDAL OATMEAL	Pipette LLC	39829827-d801-f5a7-e063-6394a90a024c	2025-07-09	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Westminster Pharmaceuticals, LLC	7e045b3a-f33b-4faa-ab9b-2baec6ff7924	2025-07-08	Warnings	Exact identifier application number: M016
Desitin Multi-Purpose Healing	PETROLATUM	Kenvue Brands LLC	30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab	2025-07-07	Warnings	Exact identifier application number: M016
Astringent Solution	ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE	First Nation Group	065c895c-7d86-f1ed-e063-6394a90a3a52	2025-07-07	Warnings	Exact identifier application number: M016
Creamy Petroleum	PETROLATUM	Savvy Care & Cosmetics Pvt Ltd	3916daee-f8d2-e3f0-e063-6294a90a3883	2025-07-04	Warnings	Exact identifier application number: M016
Exemax Cream	DIMETHICONE, ALLANTOIN	PureTek Corporation	38e79055-df84-d314-e063-6394a90ac95f	2025-07-01	Warnings	Exact identifier application number: M016
Procure Dimethicone 5%	DIMETHICONE	Twin Med LLC	38a7e4af-997d-549e-e063-6394a90a0bd6	2025-06-28	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Derma Sciences Canada Inc.	37eff762-1ea9-ec66-e063-6394a90a3d10	2025-06-19	Warnings	Exact identifier application number: M016
Dr.Johnes SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	b731c55e-31ee-429f-8432-fac7c5718d83	2025-06-18	Warnings	Exact identifier application number: M016
Dr. Johne SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	6c5adc3c-9d45-449a-ad42-f9571851cd18	2025-06-18	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal	OATMEAL	THERAPLEX, LLC	e51aa467-ffe7-4c6b-8588-6df8592596d4	2025-06-16	Warnings	Exact identifier application number: M016
ZIIDII Wild Yam Cream	WILD YAM	Guangzhou Haishi Biological Technology Co., Ltd.	3733154a-4884-9988-e063-6294a90aa78c	2025-06-10	Warnings	Exact identifier application number: M016
Aveeno Calm Plus Restore Skin Therapy Balm	COLLOIDAL OATMEAL	Kenvue Brands LLC	dbe7a2cc-9c21-2a48-e053-2a95a90a54e2	2025-06-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	WALGREENS	2017113f-d192-5fbb-e063-6294a90a83b0	2025-05-31	Warnings	Exact identifier application number: M016
AHHH Bite Relief	SODIUM BICARBONATE	78271	25a1e070-9228-4ec9-e063-6294a90ad78d	2025-05-27	Warnings	Exact identifier application number: M016
SupreH Bee Venom Skin Tag Treatment Liquid	SUPREH BEE VENOM SKIN TAG REMOVER LIQUID	Shenzhen Xinxin Yunhai Technology Co., Ltd.	35ca9836-917a-b0ac-e063-6294a90a28a2	2025-05-23	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Bed Sore Relief	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d2738c-dacf-7309-e063-6294a90aab4c	2025-05-23	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