NDC 0641-6189-01 - Phenylephrine 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: 0641-6189
Requested NDC: 0641-6189-01
Package NDCs from labels: 0641-6189-01, 0641-6189-10
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2026-08-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Phenylephrine Hydrochloride - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6189-01	Phenylephrine Hydrochloride	10 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION	10		12
0641-6189-10	Phenylephrine Hydrochloride	10 in 1 CARTON	INJECTION	10		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6189	PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.]	12	Current NDC, Legacy NDC, 2 package rows	20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6189-01	ML - Milliliter	0641-6189	00aeee8b-5ac4-430f-b86f-1f94e0f8cfb8	1	2019-09-05
0641-6189-10	ML - Milliliter	0641-6189	a794ad5a-0a96-432d-b8cc-38d14e1f1004	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6

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 79 of 121 · 2,401 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	8eb172da-dcd4-4660-4a8f-ad44a14b4af7	2024-11-06	Adverse reactions	Exact identifier unii: 451W47IQ8X
Licefreee Everyday	SODIUM CHLORIDE	Tec Laboratories,Inc.	407b5fd6-2331-2ba7-e054-00144ff88e88	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Licefreee	HEAD LICE TREATMENT	Tec Laboratories, Inc.	08c9d3dd-7177-0148-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Bladder Relief	CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS	Magni Company	5d0db70c-6360-493b-bcf2-8dbc95314140	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
Vaccines	ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS	Liddell Laboratories, Inc.	6e6e67d4-089e-4775-b4a4-5511953f6e3f	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
Gluten Detox	BARLEY (GRAIN), CARBO VEGETABILIS, CINCHONA OFFICINALIS, GLUTEN, GLYPHOSATE, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PANCREAS SUIS, PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN)	Liddell Laboratories, Inc.	706f2e33-8674-4911-ba0a-4efc935e7739	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
Derma Pain	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Liddell Laboratories, Inc.	e02a5e99-aa27-4276-a785-7b5328d89fdc	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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