L-Topical CALAMINE 8% PRAMOXINE HCL 1%

Product NDC: 73921-036
Requested package NDC: 73921-036-04
11-digit product format: 739210036
Labeler code: 73921
Product ID: 73921-036_a6485c0e-54aa-4ebf-acc8-fe6a513e4882
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine, Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-04-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: 80 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	73921-036	73921-036-04	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73921-036-04	2023-02-08	C162847	48780-1	f386c649-c150-0266-e053-dadaa90a7c1a	L-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION
73921-036-04	2023-01-30	C162847	48780-1	f386c649-c150-0266-e053-dadaa90a7c1a	L-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
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
73921-036-04	73921003604	118 mL in 1 CONTAINER (73921-036-04)	118 ml	2021-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
L-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION	GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED	2021-03-30	HUMAN OTC DRUG LABEL	1

L-Topical CALAMINE 8% PRAMOXINE HCL 1%

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#