Severe Allergy And Sinus Headache

Product NDC: 59779-543
11-digit product format: 597790543
Labeler code: 59779
Product ID: 59779-543_8e52652c-f124-43d4-b028-b99cda31f122
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-06-27
Marketing end: 2028-03-31
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 25; 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
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: Severe Allergy And Sinus Headache
Brand name suffix: Maximum Strength

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	25 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
TC2D6JAD40	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
1046751	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
b3c744b8-aa93-505d-f8cf-07995da4283d	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
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
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
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
59779-543-09	Severe Allergy And Sinus HeadacheMaximum Strength	10 in 1 BLISTER PACK	TABLET, FILM COATED	10		18
59779-543-09	Severe Allergy And Sinus HeadacheMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-543-09	EA - Each	59779-543	b0355b7f-a735-4f31-a74a-c8ef4db7ce33	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-543	SEVERE ALLERGY AND SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	17	Current NDC, Legacy NDC, 2 package rows	20250217_b3c744b8-aa93-505d-f8cf-07995da4283d.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 96 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c5027f-9701-fb07-e053-2a95a90a6029	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8c052d8-fb9f-09f2-e053-2a95a90a37af	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c53c14-ba82-2c68-e053-2a95a90a9894	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Severe Sinus	OXYMETAZOLINE HCL	Gil Pharmaceutical Corp	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c08532-1169-6603-e053-2a95a90a3484	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c59e6d-c11c-2664-e053-2a95a90a8333	2025-10-09	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
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046751	acetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	b3c744b8-aa93-505d-f8cf-07995da4283d	18
1046751	acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	b3c744b8-aa93-505d-f8cf-07995da4283d	18
1046751	APAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	b3c744b8-aa93-505d-f8cf-07995da4283d	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-543-09	59779054309	2 BLISTER PACK in 1 CARTON (59779-543-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2007-06-27	2028-03-31	No	No	Current