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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novita Petrolatum Jelly Pink	PETROLATUM	Shield Line LLC	3e9d4992-5c1a-16d9-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Novita Pure Petrolatum Jelly	PETROLATUM	Shield Line LLC	3c55614f-932d-4898-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Arthcal Bioidentical Peach Cream	ARTHCAL BIOIDENTICAL PEACH CREAM	Beijing JUNGE Technology Co., Ltd.	3c77f787-b7dd-6813-e063-6394a90aa004	2025-08-16	Boxed warning, Warnings	Exact identifier application number: M016
Natureplex Diaper Rash	ZINC OXIDE	Natureplex LLC	41fe8db3-727c-4bbe-a5ea-62efee4b97b0	2025-08-15	Warnings	Exact identifier application number: M016
Aloe Vera Petrolatum Jelly	PETROLATUM	Shield Line LLC	fdf3b90e-a434-49b2-e053-6394a90ab175	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm PeriShield	ZINC OXIDE	Shield Line LLC	417f1541-d65a-4612-b96b-e6183fbef1f3	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm Vitamin A D	WHITE PETROLATUM	Shield Line LLC	b73a8fc9-fa00-774a-e053-2995a90afd1e	2025-08-15	Warnings	Exact identifier application number: M016
Baby Petrolatum Jelly	PETROLATUM	SHIELD LINE LLC	35c163e6-ae41-2791-e054-00144ff8d46c	2025-08-15	Warnings	Exact identifier application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	Shield Line LLC	890ba245-ef37-4c62-ae82-980cb78acfb6	2025-08-15	Warnings	Exact identifier application number: M016
Earth Mama Eczema Cream	COLLOIDAL OATMEAL	Earth Mama Angel Baby, LLC	bd30b525-f68c-4786-9fbc-745e2634c6bb	2025-08-12	Warnings	Exact identifier application number: M016
Vitacilina Bebe Diaper Rash	ZINC OXIDE	Taisho Pharmaceutical California Inc.	6701e929-700e-40a4-9117-81e36577bfe1	2025-08-07	Warnings	Exact identifier application number: M016
Durma DynaGel	DURMA DYNAGEL	Dynarex Corporation	3bcbe314-98ca-78f1-e063-6394a90a13ad	2025-08-07	Warnings	Exact identifier application number: M016
Bath Bomb 2-pack (Lemon)	ALLANTOIN	Carolina Cannabis Creations LLC	08c7c313-cf36-fb46-e063-6294a90a7304	2025-08-06	Warnings	Exact identifier application number: M016
Earthmed Lip Balm Strawberry Rhubarb	ALLANTOIN	Earthmed LLC	3b54eea1-2e09-2ee1-e063-6294a90a52e5	2025-08-05	Warnings	Exact identifier application number: M016
ProCure Skin Repair Cream	DIMETHICONE 1.5%	Twin Med LLC	3ba3d3b3-ab13-ea80-e063-6394a90ad459	2025-08-05	Warnings	Exact identifier application number: M016
Earthmed FS Hand and foot	ALLANTOIN	Earthmed LLC	3ba592e9-2ef1-d20a-e063-6394a90a9bae	2025-08-05	Warnings	Exact identifier application number: M016
Earthmed FS massage oil	ALLANTOIN	Earthmed LLC	3ba64ad2-61b1-8021-e063-6294a90a7335	2025-08-05	Warnings	Exact identifier application number: M016
Petroleum Jelly	BABY PETROLEUM JELLY	NeilMed Pharmaceuticals Inc.	3b861e02-671a-c9e5-e063-6394a90a8d0f	2025-08-04	Warnings	Exact identifier application number: M016
Earthmed Sport massage oil	ALLANTOIN	Earthmed LLC	3b92e87d-ba8d-4bac-e063-6294a90a106e	2025-08-04	Warnings	Exact identifier application number: M016
EA EIGHT HOUR SKIN PROTECTANT	PETROLATUM	REVLON	b590991c-8ec8-67c2-e053-2a95a90a3acf	2025-08-01	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