Calamine

Product NDC: 68788-0292
11-digit product format: 687880292
Labeler code: 68788
Product ID: 68788-0292_671e5bc7-7fa2-48d7-b251-9b1249d2dfa6
Type: HUMAN OTC DRUG
Nonproprietary name: FERRIC OXIDE RED
Dosage form: LOTION
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: 347
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-04-19
Substance: FERRIC OXIDE RED; ZINC OXIDE
Active strength: 8; 8 g/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Calamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	8 g/mL
ZINC OXIDE	8 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
326f3d80-c1bf-4cf0-a662-58e02ed7ee67	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-0292-1	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-0292-1	ML - Milliliter	68788-0292	f4aef026-c890-422d-90f1-6ad4552ab24a	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0292	CALAMINE (FERRIC OXIDE RED) LOTION [PREFERRED PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250215_326f3d80-c1bf-4cf0-a662-58e02ed7ee67.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Preferred Pharmaceuticals Inc.	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	2025-02-12	Warnings, Adverse reactions	Exact identifier ndc (product): 68788-0292

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	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-0292-1	68788029201	177 mL in 1 BOTTLE, PLASTIC (68788-0292-1)	177 ml	2018-04-19	0000-00-00	No	No	Current