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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mederma PM	DIMETHICONE	PMI Branded Pharmaceuticals, Inc.	26737285-f6ae-47eb-9019-33f1cfce3029	2026-07-15	Warnings	Exact identifier application number: M016
MEDERMA STRETCH MARKS THERAPY	DIMETHICONE	L. Perrigo Company	e9366775-e85b-4403-a2c5-12d9fb3cc3fa	2026-07-15	Warnings	Exact identifier application number: M016
Remedy Barrier Cream Cloths Fragrance Free	DIMETHICONE	Medline Industries, LP	00e0cd4a-6049-408a-ab3f-9edf97e6438a	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	3e61191a-e0fa-3477-e063-6294a90a7d19	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	459a90b8-7d52-ef70-e063-6394a90ac1d0	2026-07-14	Warnings	Exact identifier application number: M016
Mederma for Kids	ALLANTOIN	L. Perrigo Company	ed4ff435-9819-46d3-9375-914712943f77	2026-07-14	Warnings	Exact identifier application number: M016
Baby 3-in-1 Diaper Rash	BABY 3-IN-1 DIAPER RASH	Walgreens	5632dde2-f59d-3a45-e063-6394a90a1a24	2026-07-09	Warnings	Exact identifier application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTH	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	161ba174-1b13-83cd-e063-6394a90af19c	2026-07-09	Warnings	Exact identifier application number: M016
Drs. Hydrocortisone Aloe Vera	HYDROCORTISONE	OL PHARMA TECH,LLC	0df06415-5d32-7ef8-e063-6294a90a6e5a	2026-07-09	Warnings	Exact identifier application number: M016
SOHEJU Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	560089ff-3361-90b7-e063-6294a90ada42	2026-07-09	Warnings	Exact identifier application number: M016
Bee Venom Psoriasis Wart Caring Cream	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	563a423c-e9dd-1cab-e063-6294a90a8c6a	2026-07-09	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson Medical-Surgical Inc.	46df52c8-0cbf-213e-e054-00144ff88e88	2026-07-08	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson	5abe1b34-f71b-2a90-e053-2991aa0aded6	2026-07-08	Warnings	Exact identifier application number: M016
Walgreens Baby Healing Balm	PETROLATUM	Walgreens	561c1e1e-e896-d6e9-e063-6394a90ac0e7	2026-07-08	Warnings	Exact identifier application number: M016
AD Overnight Healing	AD OVERNIGHT HEALING	WellSpring Pharmaceutical Corporation	57c29db6-da0c-4b28-86c0-6ac1b7122428	2026-07-07	Warnings	Exact identifier application number: M016
EczeNourish Eczema and Psoriasis Soothing Oat	COLLOIDAL OATMEAL	Vanguard Soap, LLC	55f7137f-c5a5-f2ce-e063-6394a90a5280	2026-07-07	Warnings	Exact identifier application number: M016
FDS intimate Whole Body Medicated Chafing	FDS INTIMATE WHOLE BODY MEDICATED CHAFING	WellSpring Pharmaceutical Corporation	ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c	2026-07-07	Warnings	Exact identifier application number: M016
AD First Aid Multipurpose	AD FIRST AID MULTIPURPOSE	WellSpring Pharmaceutical Corporation	999989d8-21c2-4380-b4c1-e5421189f6ed	2026-07-07	Warnings	Exact identifier application number: M016
AD Anti-Chafing	AD ANTI-CHAFING	WellSpring Pharmaceutical Corporation	d272ab4a-eb18-4f64-b925-fccf637dbb02	2026-07-06	Warnings	Exact identifier application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BAR	COLLOIDAL OATMEAL SKIN PROTECTANT	Vanguard Soap, LLC	55f865dc-d88e-fe2f-e063-6294a90aa7d3	2026-07-06	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