Calamine

Product NDC: 11344-336
Requested package NDC: 11344-336-30
11-digit product format: 113440336
Labeler code: 11344
Product ID: 11344-336_dfc3ed13-fb7b-44fa-b722-bda4058a5a41
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine, Pramoxind HCl
Dosage form: LOTION
Route: TOPICAL
Labeler: Vi-Jon, LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-09-08
Marketing end: 0000-00-00
Substance: FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength: 80 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11344-336	11344-336-30	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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11344-336	11344-336-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11344-336	11344-336-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11344-336-30	ML - Milliliter	11344-336	cb6a3979-939f-4690-9a3c-558664ae9575	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11344-336	CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [CONSUMER PRODUCT PARTNERS, LLC]	3	Legacy NDC	20240314_482898e5-ec45-4582-b61b-cedc1ed32a92.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11344-336-30	11344033630	177 mL in 1 BOTTLE, PLASTIC (11344-336-30)	177 ml	2016-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Good Sense 336.003/336AG Medicated Calamine Lotion	Consumer Product Partners, LLC	2024-03-12	HUMAN OTC DRUG LABEL	3