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 168 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	3dc293c9-736b-4bd8-b993-ff83b9909bcd	2024-02-23	Warnings	Exact identifier application number: M012
Childrens Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health (Leader) 70000	10cc7d67-30c4-4451-bf74-78abae3c8e25	2024-02-23	Warnings	Exact identifier application number: M012
Nasal Spray, 24-7 for Life	OXYMETAZOLINE HYDROCHLORIDE 0.05%	Lil' Drug Store Products, Inc.	11d27c75-fd95-f9da-e063-6394a90ac6b0	2024-02-20	Warnings	Exact identifier application number: M012
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	Warnings	Exact identifier application number: M012
Severe Sinus Relief Mist	OXYMETAZOLINE SPRAY	Walgreens Company	847f47d9-62b1-49a3-8bb3-9bf275685bd2	2024-02-14	Warnings	Exact identifier application number: M012
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	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