Allergy Plus Sinus Headache

Product NDC: 55910-464
11-digit product format: 559100464
Labeler code: 55910
Product ID: 55910-464_c3ce7278-9eab-4f9b-8cc4-d79e4b090da6
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DOLGENCORP, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-15
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 12.5; 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: 2027-12-31
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: Allergy Plus Sinus Headache
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 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
1233575	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
f2eacb1b-8b29-41ec-828a-c1f902ac0934	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-464-08	Allergy Plus Sinus Headache	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		19
55910-464-08	Allergy Plus Sinus Headache	2 in 1 CARTON	TABLET, FILM COATED	2		19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-464	ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]	18	Current NDC, Legacy NDC, 2 package rows	20240719_f2eacb1b-8b29-41ec-828a-c1f902ac0934.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 90 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
G-Supress DX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5dd44337-f3aa-4e73-a206-4a29850a2f7c	2025-11-12	Warnings	Exact identifier application number: M012
Allergy Relief Complete	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	15b3de6c-7ccc-408b-8789-d0e2f21a8835	2025-11-12	Warnings	Exact identifier application number: M012
PRESGEN PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	12fb91e5-6059-4b3a-a2de-762aa51a25b7	2025-11-12	Warnings	Exact identifier application number: M012
Sorbugen	DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE	Kramer Novis	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	2025-11-12	Warnings	Exact identifier application number: M012
DESGEN DM	DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL	Kramer Novis	6ab47174-e1fd-47ce-8788-06b7cdad5218	2025-11-12	Warnings	Exact identifier application number: M012
Presgen	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Kramer Novis	edad7a86-0d27-4a98-85b2-4b6725904f28	2025-11-12	Warnings	Exact identifier application number: M012
TUSSI PRES PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	b01a45df-3cea-4729-80c1-7f35b7f707f0	2025-11-12	Warnings	Exact identifier application number: M012
TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	e966b75c-4bb4-4216-8247-baada8f5d759	2025-11-12	Warnings	Exact identifier application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	52327ed0-ea49-4d1c-b928-20ab381be9f2	2025-11-11	Warnings	Exact identifier application number: M012
TOPCO Childrens Cough Relief	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Topco Associates, LLC	ee0f5627-5104-4990-88ee-2fb46965bc1e	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Childrens Cold and Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates, LLC	8931d4ca-c599-49be-87e1-8c0598f38b77	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	01c517e5-d693-4926-9eb5-4b894a2f6917	2025-11-11	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435b4a2a-d6bf-ec25-e063-6294a90a3f06	2025-11-11	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435e6387-1ee0-c20f-e063-6294a90adac5	2025-11-11	Warnings	Exact identifier application number: M012
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b	2025-11-10	Warnings	Exact identifier application number: M012
TOPCARE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	Topco Associates, LLC	b5e15dd1-6e99-411c-9183-8a4265eae404	2025-11-08	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	103de130-ef12-4c58-bbcf-234b3f3b2cbf	2025-11-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	2b3fbab9-92b5-42a7-b27b-ff46350ce055	2025-11-07	Warnings	Exact identifier application number: M012
Robitussin Day and Night Maximum Strength Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b43d8fbd-1977-4465-aa64-79e7b7f54e09	2025-11-07	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	093649a4-f968-49bd-83af-bb7e0f448ecf	2025-11-07	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
1233575	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f2eacb1b-8b29-41ec-828a-c1f902ac0934	19
1233575	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f2eacb1b-8b29-41ec-828a-c1f902ac0934	19
1233575	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	SY	f2eacb1b-8b29-41ec-828a-c1f902ac0934	19
1233575	APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	f2eacb1b-8b29-41ec-828a-c1f902ac0934	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-464-08	55910046408	2 BLISTER PACK in 1 CARTON (55910-464-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dollar General 44-464	DOLGENCORP, LLC \| LNK International, Inc.	2026-07-06	HUMAN OTC DRUG LABEL	20