Theraflu ExpressMax

Product NDC: 0067-8127
11-digit product format: 000678127
Labeler code: 0067
Product ID: 0067-8127_5239b4c6-3ff8-4309-88c1-800335104e40
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: SYRUP
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-07-15
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 20; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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: Theraflu ExpressMax
Brand name suffix: Daytime Severe Cold and Cough
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/30mL

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
9D2RTI9KYH	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
1113705	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
ff48b55a-0d32-47d6-941d-d99c7cf52f94	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-8127-08	Theraflu ExpressMaxDaytime Severe Cold and Cough	245.5 mL in 1 BOTTLE	SYRUP	245.5		7
0067-8127-08	Theraflu ExpressMaxDaytime Nighttime Value Pack	245.5 mL in 1 BOTTLE	SYRUP	245.5 mL	650 mg in 30mL	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-8127-08	ML - Milliliter	0067-8127	4a12dcda-93eb-4af2-9b2f-0087f435a47f	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8127	THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 1 package rows	20240214_ff48b55a-0d32-47d6-941d-d99c7cf52f94.zip
0067-8127	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC	20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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 76 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Cherry Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72db7f0-9324-8ed2-e053-2995a90a9868	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72e557f-0211-81b9-e053-2995a90a1437	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Cherry Benzocaine Lozenges	BENZOCAINE	Geiss, Destin, Dunn	c7404c94-09eb-5cc5-e053-2995a90af021	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense SF Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	e11ed21f-6ceb-5908-e053-2995a90aea46	2025-12-12	Warnings	Exact identifier application number: M012
Severe Congestion Relief Maximum Strength Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	59918b8b-5c91-468f-834e-66020dc1ae12	2025-12-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	SALADO SALES INC.	8f66f5bc-7c77-420b-9feb-911c980fbfdc	2025-12-12	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	de55a9fd-53a2-4f3e-82b7-cabcbe287d46	2025-12-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	SALADO SALES INC.	cc73b668-cc6a-41d6-800a-4988c59c0449	2025-12-12	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	75269bcc-3bb2-49a0-8788-6b7da18796d3	2025-12-12	Warnings	Exact identifier application number: M012
Suphedrine PE Sinus plus Allergy	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	affac07f-d645-4999-98ee-7467902f5adc	2025-12-12	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	WinCo Foods, LLC	f7e925f4-7da6-4157-a97f-e6a3e399911f	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	645f8075-e33f-4e1a-9249-7368261cdcb9	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	8fd0071b-c6ca-49e6-b159-45dead71b664	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	098582dc-3e12-782f-e063-6394a90aa1a1	2025-12-11	Warnings	Exact identifier application number: M012
GUAIASORB DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	09866b9c-aa32-45eb-e063-6394a90a4903	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d6947661-a6dd-4bc4-a0ca-932db1840f58	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	2e751d67-51b4-4b74-a9e8-7f3bc5636984	2025-12-11	Warnings	Exact identifier application number: M012
Pressure and Pain Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	232acb86-7383-4992-b333-1e47bf7c06ad	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	72847721-9f59-4af1-8f20-dc8449742918	2025-12-11	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401317-0295-14b3-e053-2a95a90acbb4	2025-12-11	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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	ff48b55a-0d32-47d6-941d-d99c7cf52f94	7
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	ff48b55a-0d32-47d6-941d-d99c7cf52f94	7
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	ff48b55a-0d32-47d6-941d-d99c7cf52f94	7
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	ff48b55a-0d32-47d6-941d-d99c7cf52f94	7
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	ff48b55a-0d32-47d6-941d-d99c7cf52f94	7
1803669	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack	GPCK	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1803669	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1803669	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) Pack	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8127-08	00067812708	245.5 mL in 1 BOTTLE (0067-8127-08)	245.5 ml	2015-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-04-10	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-02-12	HUMAN OTC DRUG LABEL	7