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: 2025-11-07
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.	2025-11-07	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 2 of 741 · 14,818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Blue Antibacterial Foaming Skin Cleanser	BENZALKONIUM CHLORIDE	Betco Corporation, Ltd	aa8f5b05-882d-d05a-e053-2995a90abaea	2026-09-09	Warnings	Exact identifier unii: F5UM2KM3W7
Touchland Glow Mist Hand Sanitizer Rosewater	ALCOHOL	Church & Dwight Co., Inc.	5a850866-bc5d-e595-e063-6394a90a335f	2026-09-09	Warnings	Exact identifier unii: 3K9958V90M
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier unii: FZ989GH94E
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-09-09	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC.	5b150cd2-fac8-86ce-e063-6294a90a67b9	2026-09-09	Warnings, Adverse reactions	Exact identifier rxcui: 198039 unii: G59M7S0WS3
Low Dose Aspirin	ASPIRIN	Strategic Sourcing Services LLC	7ce4807e-7bd5-41f1-a9c7-1f3af6acdc09	2026-09-09	Warnings	Exact identifier unii: R16CO5Y76E
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier unii: 451W47IQ8X
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Dextrose	DEXTROSE MONOHYDRATE	Henry Schein, Inc.	8cf6943f-16e8-4521-863c-09bb0b55e2a9	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: NDA019445 rxcui: 727517 unii: LX22YL083G
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen Extra Strength	ACETAMINOPHEN	Wal-Mart Stores Inc	78874258-16cc-40b5-9e15-5943eddfce94	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier unii: 339NCG44TV
Alcohol Prep Pad Medium	ALCOHOL PREP PAD	Yangzhou Huanrui Medical Technology Co., Ltd	5af3eedc-d01e-c9e9-e063-6394a90a49e1	2026-09-08	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Rectiv	NITROGLYCERIN	Allergan, Inc.	603aa9ed-54c4-4a35-ade4-690fa44850e4	2026-09-08	Warnings, Adverse reactions	Exact identifier unii: G59M7S0WS3
Verifine	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co., LTD	5af9f31b-0c92-e3a9-e063-6394a90a38c9	2026-09-08	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Verifine	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co., LTD	5afc0201-490e-ccf3-e063-6394a90aadad	2026-09-08	Warnings	Exact identifier application number: M003 rxcui: 797544 unii: ND2M416302
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OF	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	01906eed-78ee-f2a1-e063-6294a90a809b	2026-09-08	Warnings	Exact identifier unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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