Zinc Oxide

Product NDC: 87236-007
Requested package NDC: 87236-007-28
11-digit product format: 872360007
Labeler code: 87236
Product ID: 87236-007_5101e1fe-dffa-1e92-e063-6394a90ae61f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide 20%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Aldermed Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-12-01
Substance: ZINC OXIDE
Active strength: 20 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
Brand name suffix: Skin Protectant
Listing expiration: 2027-12-31

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
a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
87236-007-01	Zinc OxideSkin Protectant	1 in 1 CARTON	OINTMENT	1	5
87236-007-01	Zinc OxideSkin Protectant	30 g in 1 TUBE	OINTMENT	30	5
87236-007-16	Zinc OxideSkin Protectant	454 g in 1 JAR	OINTMENT	454	5
87236-007-28	Zinc OxideSkin Protectant	1 in 1 CARTON	OINTMENT	1	5
87236-007-28	Zinc OxideSkin Protectant	28.4 g in 1 TUBE	OINTMENT	28.4	5
87236-007-56	Zinc OxideSkin Protectant	56.6 g in 1 TUBE	OINTMENT	56.6	5
87236-007-56	Zinc OxideSkin Protectant	1 in 1 CARTON	OINTMENT	1	5

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 63 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016
Premier Value Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Consortium	5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Medicated Calamine	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO.	5d6c668a-80b4-de18-e053-2991aa0a38fb	2023-12-20	Warnings	Exact identifier application number: M016
Premiere Value Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Consortium	5c8bde5a-591d-085f-e053-2991aa0a56af	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO	5d6c51b8-47f8-c38b-e053-2991aa0a0f23	2023-12-20	Warnings	Exact identifier application number: M016
Health Care Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Great Lakes Wholesale, Marketing and Sales Inc	5d8f02fb-0794-8ec2-e053-2991aa0aac63	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teetter Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Harris Tetter, LLC.	5c7a7418-c973-2869-e053-2991aa0ab4f5	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teeter Calamine	ZINC OXIDE	Harris Teeter, LLC.	86021cc5-fea7-4363-8fb2-2b0484437fe8	2023-12-20	Warnings	Exact identifier application number: M016
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	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	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	5
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	5
198911	zinc oxide 20 % Topical Ointment	SY	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	5
198911	zinc oxide 200 MG per GM Topical Ointment	SY	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	5
198911	ZNO 0.2 MG/MG Topical Ointment	SY	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87236-007-28	87236000728	1 TUBE in 1 CARTON (87236-007-28) / 28.4 g in 1 TUBE	1 tube	2025-12-01	No	No	Current