NDC 0641-1495-31 - 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: 0641-1495
Requested NDC: 0641-1495-31
Package NDCs from labels: 0641-1495-31, 0641-1495-35
Manufacturer: Henry Schein, Inc.
Effective date: 2026-10-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Promethazine HCL 25 mg/mL Injection, USP 1 mL Single Dose Ampule	Henry Schein, Inc.	2026-10-12	HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride Injection, USP	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride Injection, USP	REMEDYREPACK INC.	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-02	HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - General Injectables & Vaccines, Inc	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, Inc	Aerospace Accessory Service, Inc	2021-05-18	MEDICAL DEVICE
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit
Promethazine Hydrochloride Injection, USP Rx only	Dispensing Solutions Inc.	2010-03-02	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-1495-31	Promethazine Hydrochloride	1 mL in 1 AMPULE	INJECTION	1		5
0641-1495-35	Promethazine Hydrochloride	25 in 1 CARTON	INJECTION	25		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-1495	PROMETHAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240412_13d9e59d-eadb-41d5-9f47-9c11a6efb31c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-1495-31	ML - Milliliter	0641-1495	8f71d813-efd2-4f08-b2fa-1b5da840c091	1	2012-07-24
0641-1495-35	ML - Milliliter	0641-1495	4630f281-0707-4994-872a-ee7bd8a6722d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	5
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	5
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

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 5 of 733 · 14,658 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton Candy	ALCOHOL	Church & Dwight Co., Inc.	5aaaf5a5-d43f-cf23-e063-6394a90a72ef	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach Coco	ALCOHOL	Church & Dwight Co., Inc.	5aaaff8f-5f6b-d575-e063-6394a90a1edc	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight Smores	ALCOHOL	Church & Dwight Co., Inc.	5aab0ca1-b3c4-964f-e063-6294a90a263f	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry Fizz	ALCOHOL	Church & Dwight Co., Inc.	5aab1faa-d884-1a55-e063-6394a90ad6e2	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: 03J5ZE7KA5
Members Mark	ISOPROPYL ALCOHOL	Sams West Inc	c251ac50-f74f-4a48-e053-2a95a90aac0d	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2f1342ef-1843-40a6-e063-6294a90a577f	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Curad Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Medline Industries, LP	1ce3872e-2307-4a38-bd7d-7eb2b226cf3c	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Alcohol	ISOPROPYL ALCOHOL	SuperValu, Inc.	5e6e6d6f-4472-40f1-b0a9-96cee7ef075b	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Alcohol	ISOPROPYL ALCOHOL	Foodhold U.S.A. LLC	a94c023c-5313-4940-90a7-b3061a8b90e1	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Meijer	ISOPROPYL ALCOHOL	Meijer Distribution Inc	ca008d84-cf51-3703-e053-2a95a90a9bf1	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2eff98ba-5736-b07e-e063-6394a90aeea9	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: FZ989GH94E
Walgreen Alcohol	ISOPROPYL ALCOHOL	Walgreens Company	deeae1ea-3d81-4260-95be-c4f328e3fdef	2026-09-04	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Tree Pollen	ACER NEGUNDO, ACER RUBRUM, ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, BETULA NIGRA, EUPHRASIA OFFICINALIS, FRAXINUS AMERICANA, HISTAMINUM HYDROCHLORICUM, LIGUSTRUM VULGARE, LIQUIDAMBAR STYRACIFLUA, MORUS ALBA, PINUS STROBUS, POPULUS DELTOIDES, QUERCUS RUBRA, SABADILLA, SALIX NIGRA, SANGUINARIA CANADENSIS	NaturalCare	feea837e-7ce3-4575-8cb8-451f5385cf97	2026-09-03	Warnings	Exact identifier unii: YKH834O4BH
EPINEPHRINE	EPINEPHRINE	REMEDYREPACK INC.	55befbe4-c819-4367-bbe7-de5841786aac	2026-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 1660014 unii: YKH834O4BH
nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	89da40c1-bab1-422e-b326-8ebcbdbc81f3	2026-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 198039 unii: G59M7S0WS3
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed3796ee-3078-e850-e053-2a95a90a318a	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed63bd55-941f-9785-e053-2995a90a5952	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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