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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProCure LanaCare	LANOLIN 30%	Twin Med LLC	3aad8395-6dc2-f600-e063-6294a90a6e9a	2025-09-15	Warnings	Exact identifier application number: M016
ProCure DryDrox	ALUMINUM HYDROXIDE GEL 2%	Twin Med LLC	3ab4efb6-bd31-2583-e063-6294a90a415b	2025-09-15	Warnings	Exact identifier application number: M016
ProCure Petroleum	100% WHITE PETROLATUM	Twin Med LLC	3eddf0e7-8e9d-a311-e063-6394a90ad156	2025-09-15	Warnings	Exact identifier application number: M016
NOURISHING HAND SANITIZER SPRAYS	CHLORHEXIDINE DIGLUCONATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3e95a30c-8ed3-30ed-e063-6294a90a2417	2025-09-12	Warnings	Exact identifier application number: M016
I.C. Ivy Block	ZINC ACETATE	R & R Lotion, Inc	db263f4a-56a1-432c-b2e8-2a9bdd3ff129	2025-09-10	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Cream	COLLOIDAL OATMEAL 1%	RoyceDerm LLC	3e09f000-01d2-0d21-e063-6294a90ac548	2025-09-05	Warnings	Exact identifier application number: M016
Healing Hand Cream	ALLANTOIN	Carolina Cannabis Creations LLC	3dd5887f-a26b-01ef-e063-6394a90a0c52	2025-09-02	Warnings	Exact identifier application number: M016
OKeeffes Skin Repair Body Cream Eczema Relief	COLLOIDAL OATMEAL	The Gorilla Glue Company/O'Keeffe's Company	39e9ca98-d0e6-6b8f-e063-6394a90aa366	2025-09-01	Warnings	Exact identifier application number: M016
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3d379d5b-e939-9391-e063-6294a90a375c	2025-08-25	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3d1fd588-8d16-509c-e063-6394a90ad025	2025-08-24	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MY IMPORTS USA LLC	3d2000da-a173-1fc3-e063-6294a90ad3a9	2025-08-24	Warnings	Exact identifier application number: M016
Foaming Facial Cleanser	GLYCERIN, NIACINAMIDE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	396c1db9-a5d3-cc82-e063-6294a90a90bb	2025-08-23	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3cf22c5a-f9a0-4bfb-e063-6394a90af8dd	2025-08-22	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A D	LANOLIN, PETROLATUM	MY IMPORTS USA LLC	3cf37fa7-6be4-b835-e063-6394a90ad406	2025-08-22	Warnings	Exact identifier application number: M016
Awaken Moisturizing Cream	DIMETHICONE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	486c7f05-708a-44a1-8fc0-78344f5018db	2025-08-21	Warnings	Exact identifier application number: M016
Zinc Oxide 40%	DIAPER RASH SKIN PROTECTENT	ELEEO BRANDS LLC	2992285b-bcdb-c0da-e063-6294a90ac650	2025-08-19	Warnings	Exact identifier application number: M016
MedPride Vitamin A and D	WHITE PETROLATUM	Shield Line LLC	360085ae-29fc-41c9-9875-c902f197a871	2025-08-18	Warnings	Exact identifier application number: M016
Novita Petrolatum with Cocoa Butter	PETROLATUM	Shield line LLC	3e9c68e5-8983-1a18-e054-00144ff8d46c	2025-08-18	Warnings	Exact identifier application number: M016
Medpride	WHITE PETROLATUM	Shield Line LLC	0c4201e1-54f5-4d44-a31a-89aaa511d6b5	2025-08-18	Warnings	Exact identifier application number: M016
Novita Baby Petrolatum Jelly	PETROLATUM	Shield Line LLC	3e9cf8bf-929b-45bf-e054-00144ff8d46c	2025-08-18	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