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 14 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4523af69-1a0d-6d18-e063-6394a90ad9d1	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry	LIP BALM SKIN PROTECTANT	Suave Brands Company	47a2487d-b2e5-7195-e063-6394a90ae481	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4512b5a0-ce1f-c53e-e063-6294a90a56b6	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Strawberry	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42770fff-d70a-d9d1-e063-6294a90aa98d	2026-03-30	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Healing	GLYCERIN	Kenvue Brands LLC	345fdde5-700b-7103-e063-6394a90a0e3e	2026-03-27	Warnings	Exact identifier application number: M016
Critic Aid Clear	PETROLATUM	Coloplast Corp	0b6da97e-519b-4579-9895-f4ede5c48b47	2026-03-27	Warnings	Exact identifier application number: M016
Baza Protect	ZINC OXIDE AND DIMETHICONE	Coloplast Corp	256dfcfc-a91c-49b0-9439-452586a0880e	2026-03-27	Warnings	Exact identifier application number: M016
Sween 24	DIMETHICONE	Coloplast Corp	a623c8d7-8db0-410a-9980-02ac02f7b6ea	2026-03-27	Warnings	Exact identifier application number: M016
Baza Cleanse and Protect Odor Control	DIMETHICONE	Coloplast Corp	ca5fa4ae-c18d-4457-b520-4a9318ea821f	2026-03-27	Warnings	Exact identifier application number: M016
Baza Cleanse and Protect	DIMETHICONE	Coloplast Corp	82eff041-0c9d-4261-a6b6-5a041a660074	2026-03-27	Warnings	Exact identifier application number: M016
Baza Clear	PETROLATUM	Coloplast Corp	69d9f456-1a35-4146-8366-c0285648a172	2026-03-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Topco Associates LLC	5126fdf6-5df5-474b-bc0d-3a82dea61abb	2026-03-26	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Amazon.com Services LLC	cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff	2026-03-26	Warnings, Adverse reactions	Exact identifier application number: M016
Dynashield with Dimethicone	ZINC OXIDE	Dynarex Corporation	b5dcf9e8-4689-4a08-ae73-3a859b4cbffe	2026-03-26	Warnings	Exact identifier application number: M016
Eczema Relief Cream	COLLOIDAL OATMEAL	Lavior Pharma Inc	bdd2fc9f-2718-1d88-e053-2995a90a8682	2026-03-26	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	36f2dec8-7ffc-fc3e-e063-6294a90a76ff	2026-03-26	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	36f33001-7fec-682e-e063-6394a90a9428	2026-03-26	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	36f3b300-f32f-8881-e063-6394a90a1a2a	2026-03-26	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Dynarex Corporation	81f5092d-0632-bf47-e053-2991aa0ac563	2026-03-25	Warnings	Exact identifier application number: M016
MYEVER	ESTRIOL CREAM	Hubei Redrui Building Materials Co., Ltd.	3ed85485-a441-4c05-e063-6394a90afef5	2026-03-25	Warnings	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