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		2026-10-16
excluded package	package	36800-063	36800-063-34	D	Discontinued by firm		2026-10-16

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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petrolatum Jelly	PETROLATUM	NEW PRIDE CORP	f6634410-fa1f-7987-e053-2995a90abb06	2023-12-01	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair	DIMETHICONE	Galderma Laboratories, L.P.	27d74e0f-8359-4c59-bf7f-acade7f4545c	2023-11-30	Warnings	Exact identifier application number: M016
Sheffield Advanced Scar Gel	ADVANCED SCAR GEL	Sheffield Pharmaceuticals LLC	ab78b946-81ed-442c-a167-26c26c7fe8a1	2023-11-30	Warnings	Exact identifier application number: M016
Akin Diaper Rash	ZINC OXIDE	Southern Sales & Service, Inc.	f5515517-7977-48f9-aab6-cf0d2f2a04a0	2023-11-29	Warnings	Exact identifier application number: M016
Dr. Sheffield Diaper Rash	ZINC OXIDE	Sheffield Pharmaceuticals LLC	cac77320-b5cf-4edf-9693-ebabfb61390c	2023-11-28	Warnings	Exact identifier application number: M016
Sheffield Zinc Oxide	ZINC OXIDE	Sheffield Pharmaceuticals LLC	60b54c04-4387-4954-951d-165809947310	2023-11-28	Warnings	Exact identifier application number: M016
Cetaphil Baby Soothe and Protect Cream	ALLANTOIN	Galderma Laboratories, L.P.	38254e03-3716-4e45-86b7-06430ebadc86	2023-11-22	Warnings	Exact identifier application number: M016
Cetaphil Baby Eczema Soothing	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b	2023-11-22	Warnings	Exact identifier application number: M016
EczemaHoneyBodyLotion	COLLOIDAL OATMEAL	Allure Labs	0a710be0-562e-8368-e063-6294a90a3b1b	2023-11-18	Warnings	Exact identifier application number: M016
Zinc Oxide	SKIN PROTECTANT	BluePoint Laboratories	d9b752e6-655a-19a6-e053-2995a90a9a37	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier application number: M016
DERMA SANTE Anti Eczema Cream	OATMEAL	Hope Science Inc.	1492a6ad-016c-4307-8286-5c564de9e160	2023-11-11	Warnings	Exact identifier application number: M016
M3 NATURALS Eczema Cream	OATMEAL	M3 Naturals LLC	45e2cdde-58fb-4eea-a54d-f53f9ad0d854	2023-11-11	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	53900588-5c9e-4164-816d-017bdbb0f31b	2023-11-11	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Max Strength	ZINC OXIDE	Geodis Logistics LLC	1b4fd6cb-f2dc-40a2-b958-e99caec91793	2023-11-10	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Original	ZINC OXIDE	Geodis Logistics LLC	97587458-4ca0-4de3-9bb9-148346d859c0	2023-11-10	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