NDC 67296-0198-04 - Promethazine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 67296-0198
Requested NDC: 67296-0198-04
Package NDCs from labels: 67296-0198-4, 67296-0198-2, 67296-0198-1, 67296-0198-04
Manufacturer: Redpharm Drug
Effective date: 2026-09-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Promethazine Hydrochloride - Redpharm Drug	Redpharm Drug	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL
Promethazine 25mg	RedPharm Drug, Inc.	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67296-0198-1	2024-06-13	Promethazine 25mg
67296-0198-2	2024-06-13	Promethazine 25mg
67296-0198-1	2023-01-30	Promethazine 25mg
67296-0198-2	2023-01-30	Promethazine 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0198-1	Promethazine Hydrochloride	15 in 1 BOTTLE	TABLET	15		5
67296-0198-2	Promethazine Hydrochloride	20 in 1 BOTTLE	TABLET	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0198	PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240615_891a74cf-c4df-975d-e053-2a95a90a6872.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 7 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Proficient Rx LP	68a4c521-6db0-4e94-9906-96e96e251301	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	08bf9fbf-cc21-41a0-9e81-ec498aa64170	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Actavis Pharma, Inc.	a32255f0-0077-489e-bdc6-869aca8cd434	2016-12-01	Warnings, Adverse reactions	Exact identifier rxcui: 992475 rxcui: 992447 unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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