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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	1ac59efd-9efd-09d9-e063-6394a90a5e40	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	a3424b96-74b0-21c4-e053-2a95a90ae7ea	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	a4eb1cad-a9c0-43d3-e053-2995a90a06a0	2025-01-20	Warnings	Exact identifier application number: M016
RICO Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	dc8ba3a2-9748-ec52-e053-2995a90a638b	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer	ALCOHOL	HANUL CO.,LTD	a4fa65f9-9786-76dd-e053-2995a90a6e13	2025-01-20	Warnings	Exact identifier application number: M016
SAN Skinlab Cloth Wet Wipes	BENZALKONIUM CHLORIDE 0.13%	HANUL CO.,LTD	c058d278-3d6d-7e3c-e053-2995a90a6c2f	2025-01-20	Warnings	Exact identifier application number: M016
Rico Hand Sanitizer	ALCOHOL	HANUL CO.,LTD	a6065fcd-3968-d5a1-e053-2a95a90ab8d6	2025-01-20	Warnings	Exact identifier application number: M016
VITAMIN A and D	WHITE PETROLATUM	VIVE HEALTH LLC	2bd4465b-6e46-51e2-e063-6294a90a695f	2025-01-16	Warnings	Exact identifier application number: M016
VITAMIN A and D	WHITE PETROLATUM	VIVE HEALTH LLC	2bd4a2b0-f586-3ab1-e063-6294a90aa1ed	2025-01-16	Warnings	Exact identifier application number: M016
Dermoia Manuka Honey Eczema	OATMEAL	TREASUREWISE LLC	18c174de-6626-45ee-a6aa-f75a48daab8d	2025-01-15	Warnings	Exact identifier application number: M016
Allantoin	MEDICINAL MASSAGE OIL	Carolina Cannabis Creations L.L.C	04b5619b-2122-f159-e063-6394a90a2e05	2025-01-15	Warnings	Exact identifier application number: M016
Skin Barista 2in1 White Body Perfection	DIMETHICONE	Pioom Cosmetic Co.,ltd	2d7fc20c-31a7-195b-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M016
Skin Barista Rice Bran Cleansing Foam	ALLANTOIN	Pioom Cosmetic Co.,ltd	2d7fc7f6-1e89-116c-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M016
Hammertech Vitamin A and D	WHITE PETROLATUM	HAMMER TECH LLC	ffe96aa1-db6b-33e4-e053-6394a90a7e4e	2025-01-14	Warnings	Exact identifier application number: M016
NOON Cartessa Accelerate Program	ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	400ead81-ab07-400f-b261-db330e0fd004	2025-01-14	Warnings	Exact identifier application number: M016
NOON Post Procedure Program	ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	9d1d11b4-40ff-4ea8-a3af-655f457c05f1	2025-01-14	Warnings	Exact identifier application number: M016
OLP diaper Rash cream A and D	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	d6faa4d9-751c-a1b6-e053-2a95a90aee5b	2025-01-09	Warnings	Exact identifier application number: M016
ANTI-ITCH	ZINC ACETATE , DIPHENHYDRAMINE	OL PHARMA TECH, LLC	b79d3096-c609-e710-e053-2995a90a8da2	2025-01-09	Warnings	Exact identifier application number: M016
ANTIBACTERIAL DREAMY FLORALS	GLYCERIN	Quimicas Handal de Centroamerica SA de CV	09f73bec-516d-90f0-e063-6394a90aecab	2025-01-08	Warnings	Exact identifier application number: M016
AOAO Repair Foot Cream	UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.	Guangdong Junhui Biotechnology Co.,LTD	21064e84-c827-ca82-e063-6394a90a6c65	2025-01-08	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