Cold Medicine

Product NDC: 76095-011
11-digit product format: 760950011
Labeler code: 76095
Product ID: 76095-011_24b2650e-08a2-0752-e063-6394a90a4b90
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Midway Importing, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-27
Substance: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 2; 5 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cold Medicine
Brand name suffix: XL3
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
CHLORPHENIRAMINE MALEATE	2 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
V1Q0O9OJ9Z	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046781	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e41b9beb-e274-5c02-e053-2995a90ad0f8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76095-011-20	Cold MedicineXL3	2 in 1 BOX	TABLET	2		2
76095-011-20	Cold MedicineXL3	10 in 1 BLISTER PACK	TABLET	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76095-011	COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20241027_e41b9beb-e274-5c02-e053-2995a90ad0f8.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 35 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	ec0b5f4b-b58c-445f-acf1-c7ce301bba64	2026-04-30	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	098428ae-e87d-4c29-8f02-1590530da58e	2026-04-29	Warnings	Exact identifier application number: M012
Panadol Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	341761b9-f0be-f816-e063-6394a90a5e63	2026-04-29	Warnings	Exact identifier application number: M012
Panadol Cold and Flu Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3417993d-8e3c-23d6-e063-6394a90a7d50	2026-04-29	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	509f233e-ff01-8927-e063-6394a90a9929	2026-04-29	Warnings	Exact identifier application number: M012
Broncomiel Adults	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509c61d3-ae16-be5c-e063-6294a90a68da	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	TOP CARE (Topco Associates LLC)	aa1eb90c-e565-455f-8978-6f2f9e00a814	2026-04-29	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	e1280355-da81-489f-9bd2-ffea9a68010c	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	7b095ec5-9951-4491-9b68-7ac0a7f10053	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOP CARE (Topco Associates LLC)	98dd0ba6-0109-46b2-92df-11a030984240	2026-04-28	Warnings	Exact identifier application number: M012
Pain, Headache and Congestion	ACETAMINOPHEN, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	41a77cbb-6a4d-46a4-ab27-c7affa2cc682	2026-04-28	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	dd7da15a-4e0b-405f-e053-2995a90a06d2	2026-04-28	Warnings	Exact identifier application number: M012
CAREONE CHILDRENS COLD COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Retail Business Services, LLC	382f7d51-ceb8-4bdf-9bd5-440b50c65cd3	2026-04-28	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	1a520b4f-6a4b-4e37-94c5-9387f2e4c34a	2026-04-27	Warnings	Exact identifier application number: M012
Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kroger	49a7cd2a-8c0e-2196-e063-6294a90a134a	2026-04-27	Warnings	Exact identifier application number: M012
Guaifenesin,Dextromethorphan Hbr	GUAIFENESIN,DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	3e5d978f-cc70-60a5-e063-6394a90a67d3	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	36ced59c-12dc-441f-e063-6294a90a3239	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Softgel Healthcare Private Limited	30ab39f3-27cc-5728-e063-6394a90a9cbe	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	353f71f7-81e0-08c2-e063-6294a90acb49	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	Softgel Healthcare Pvt Ltd	353ef34f-760d-ae92-e063-6294a90a5b4a	2026-04-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046781	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	e41b9beb-e274-5c02-e053-2995a90ad0f8	2
1046781	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	e41b9beb-e274-5c02-e053-2995a90ad0f8	2
1046781	APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	e41b9beb-e274-5c02-e053-2995a90ad0f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76095-011-20	76095001120	2 BLISTER PACK in 1 BOX (76095-011-20) / 10 TABLET in 1 BLISTER PACK	2 blister pack	2022-06-27	0000-00-00	No	No	Current