Calamine

Product NDC: 36800-063
11-digit product format: 368000063
Labeler code: 36800
Product ID: 36800-063_4ab7ad96-87b5-6284-e063-6294a90ae847
Type: HUMAN OTC DRUG
Nonproprietary name: FERRIC OXIDE RED
Dosage form: LOTION
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1991-09-15
Substance: FERRIC OXIDE RED; ZINC OXIDE
Active strength: 80; 80 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-063	36800-063-26	D	Discontinued by firm		2026-10-15
excluded package	package	36800-063	36800-063-34	D	Discontinued by firm		2026-10-15

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	36800-063-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-063-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-063-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-063-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-063-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-063-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-063-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-063-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-063-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-063-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-063-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-063-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-063-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-063-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-063-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-063-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-063-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-063-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-063-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-063-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-063-26	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-063-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-063-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-063-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Calamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	80 mg/mL
ZINC OXIDE	80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
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
617954	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
2b32e720-ac71-4d60-bc06-e28a00f8a450	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-063-26	Calamine	237 mL in 1 BOTTLE, PLASTIC	LOTION	237	22
36800-063-30	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177	22
36800-063-34	Calamine	237 mL in 1 BOTTLE, PLASTIC	LOTION	237	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-063-30	ML - Milliliter	36800-063	ba0277e0-25f2-46b1-b6ce-22e95cb90c97	1	2020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-063	CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]	21	Current NDC, Legacy NDC, 3 package rows	20250416_2b32e720-ac71-4d60-bc06-e28a00f8a450.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diaper Rash	ZINC OXIDE	Target Corporation	8059f489-f144-4de5-9454-ac6c1af35dd2	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Coconut Milk and Shea Petroleum Jelly	WHITE PETROLATUM	Target Corporation	c78d9864-92e0-4ad8-8a9b-9752ac6784e8	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	043375b2-e636-4822-9e05-df2327d29986	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Valu Merchandisers Company	4113bb6e-070a-4116-a8d6-12c6b4475beb	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Valu Merchandisers Company	e5465ddd-e38c-44a4-bb9b-3edbc636576d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Valu Merchandisers Company	8b8decec-e921-4ff9-bb49-7e38e34724f6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Valu Merchandisers Company	0cccadd7-11f3-5d1f-e063-6294a90a55c4	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Valu Merchandisers Company	7c6fa37f-79b8-4409-b7a9-3f02332f887a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	014d0028-486e-4f1c-a14f-8162e393ebca	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	United Natural Foods, Inc. dba UNFI	29a3a719-5e8b-407d-b9d9-bdba26758292	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Topco Associates LLC	8acb1b47-70ed-4aa2-a7c0-e807042affc7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016 ndc (product): 36800-063
Pure petroleum	WHITE PETROLATUM	Topco Associates LLC	3babe2cf-9e6c-4f22-940f-c1fdf489f1c7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Topco Associates LLC	8d3d1ff5-4868-495d-807c-e45aa2176f63	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Topco Associates LLC	b929b159-4af5-4a03-8e7c-676a6ba2bf55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Topco Associates LLC	cd7f1727-0b6e-4993-9820-43783994efa1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Topco Associates LLC	f37f17f7-f084-4b74-8361-178d2315a476	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Topco Associates LLC	4f6af42c-f41e-455f-b94b-3793bf0b9a3f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	2b32e720-ac71-4d60-bc06-e28a00f8a450	22
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	2b32e720-ac71-4d60-bc06-e28a00f8a450	22
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	2b32e720-ac71-4d60-bc06-e28a00f8a450	22
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	2b32e720-ac71-4d60-bc06-e28a00f8a450	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-063-26	36800006326	237 mL in 1 BOTTLE, PLASTIC (36800-063-26)	237 ml	1991-09-15	0000-00-00	No	No	Current
36800-063-30	36800006330	177 mL in 1 BOTTLE, PLASTIC (36800-063-30)	177 ml	1991-09-15	0000-00-00	No	No	Current
36800-063-34	36800006334	237 mL in 1 BOTTLE, PLASTIC (36800-063-34)	237 ml	1991-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 063.001/063AA Calamine Lotion	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	22