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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Soothing Gel Cream	ALLANTOIN	Galderma Laboratories, L.P.	bab404f0-2f7a-4bac-b053-cbdc81c029b5	2025-11-24	Warnings	Exact identifier application number: M016
health beyond VITAMINS AD	PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	de87da51-cf92-402c-b60f-5f28d1724124	2025-11-23	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	00766a7b-797e-dd15-e063-6394a90af9ac	2025-11-20	Warnings	Exact identifier application number: M016
Itch Eraser Sensitive	SODIUM BICARBONATE	Tender Corporation d/b/a Adventure Ready Brands	2250525a-45c2-42ea-e063-6394a90ac001	2025-11-18	Warnings	Exact identifier application number: M016
Moisture Barrier Cream	PETROLATUM, ZINC OXIDE	Derma Sciences Canada Inc.	43e01e22-7872-8e24-e063-6394a90a17ef	2025-11-18	Warnings	Exact identifier application number: M016
terrasil Bed Sore and Pressure Sore Relief	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	d0e4a492-f833-4e92-bd4a-b0a07ce9a69e	2025-11-18	Warnings	Exact identifier application number: M016
terrasil Foot Ulcer and Sore Relief	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2776080b-3ddb-ad6c-e063-6394a90a93e0	2025-11-18	Warnings	Exact identifier application number: M016
After Bite Kids	SODIUM BICARBONATE	Tender Corporation d/b/a Adventure Ready Brands	226c1420-d771-204f-e063-6294a90af9f6	2025-11-18	Warnings	Exact identifier application number: M016
Petroleum with Cocoa	WHITE PETROLATUM	QUALITY CHOICE (Chain Drug Marketing Association)	280d4bdb-30d3-44f2-9159-3aa9a1de9a5f	2025-11-17	Warnings	Exact identifier application number: M016
After Bite X Tech	SODIUM BICARBONATE	Adventure Ready Brands	e9e49ab4-3e1f-9fd4-e053-2a95a90a775a	2025-11-17	Warnings	Exact identifier application number: M016
Diaper Rash skin protectant	LANOLIN AND PETROLATUM	Universal Distribution Centre LLC	29b5475d-6085-cfe6-e063-6294a90a7e74	2025-11-17	Warnings	Exact identifier application number: M016
DERMOGEN	ZINC OXIDE	KRAMER NOVIS	38e02d1c-c143-4da6-ad32-a3ce2861aac5	2025-11-14	Warnings	Exact identifier application number: M016
Welmedix HomeCare PRO Rapid Relief Rash Cream	PETROLATUM, ZINC OXIDE	Welmedix LLC	4382a6b4-0b1f-0822-e063-6394a90adffc	2025-11-14	Warnings	Exact identifier application number: M016
Petroleum with Cocoa	WHITE PETROLATUM	QUALITY CHOICE (Chain Drug Marketing Association)	086b6563-cb73-4874-aa42-028f5e81b60d	2025-11-13	Warnings	Exact identifier application number: M016
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	43840785-3640-9813-e063-6394a90a7770	2025-11-13	Warnings	Exact identifier application number: M016
Petroleum Jelly Baby Fresh Scent 3.53oz	PETROLATUM	Rejoice International Corp.	1309926f-ecd9-635e-e063-6294a90aaab3	2025-11-11	Warnings	Exact identifier application number: M016
Petroleum Jelly Fragrance Free 3.53oz	PETROLATUM	Rejoice International Corp.	12f8d9cc-aa77-e034-e063-6394a90a94dd	2025-11-11	Warnings	Exact identifier application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53oz	PETROLATUM	Rejoice International Corp.	1309b15b-5236-6e9f-e063-6294a90afe11	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Tremella Revitalizing Cleanser	TREMELLA FUCIFORMIS WHOLE	ODLUMIVIE	435e4736-bcef-c227-e063-6394a90a53d5	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Peptide CalmMist	PALMITOYL TRIPEPTIDE-8	ODLUMIVIE	435e6717-5fbf-5cb2-e063-6294a90a40d7	2025-11-11	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