Allergy plus Sinus Headache

Product NDC: 83059-0044
11-digit product format: 830590044
Labeler code: 83059
Product ID: 83059-0044_57355ac1-11fb-8af6-e063-6294a90a01f9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Shield Pharmaceuticals Corp
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-02
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
772d0184-8c41-40f1-bbef-7e68692eec66	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
83059-0044-1	Allergy plus Sinus Headache	15 in 1 BOTTLE	TABLET, FILM COATED	15		4
83059-0044-1	Allergy plus Sinus Headache	1 in 1 PACKAGE	TABLET, FILM COATED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83059-0044	ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG) TABLET, FILM COATED [SHIELD PHARMACEUTICALS CORP]	3	Current NDC, 2 package rows	20241228_772d0184-8c41-40f1-bbef-7e68692eec66.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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	AmerisourceBergen Drug Corp	79cefd46-bd19-4a1d-9cb1-e85ff0f12494	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Cardinal Health	8397e1b9-e83e-4c6a-b858-1663c2365840	2024-12-18	Warnings	Exact identifier application number: M012
GNP Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	AmerisourceBergen Drug Corp	63932e68-b09d-4500-bc1d-cfb2c267df1c	2024-12-18	Warnings	Exact identifier application number: M012
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Exact identifier application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	TOPCO ASSOCIATES LLC	b6c0362f-86ca-4f08-ba53-800c6df2c025	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	10cad9a7-1223-470c-9027-807891217d40	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Rugby Laboratories	5da36516-9f94-49cb-9421-0c310abcd116	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	THE KROGER CO	430c6604-93a7-4df6-a657-ba438aa61425	2024-12-18	Warnings	Exact identifier application number: M012
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	Warnings	Exact identifier application number: M012
Dollar General Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Dolgencorp, LLC	718f08d2-3757-4f3e-915e-3e4982ad090f	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	e4610d53-4459-43a0-9351-f0ac8586df60	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	Valu Merch	5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6	2024-12-17	Warnings	Exact identifier application number: M012
Chestrub	CAMPHOR MENTHOL EUCALYPTUS OIL	Delta Brands Inc	8e6f731f-c16a-41b2-9786-0cab588cfc8e	2024-12-17	Warnings	Exact identifier application number: M012
Mentholatum Nighttime Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	5539ae74-9723-480d-b35f-0a6644bf54ad	2024-12-17	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	772d0184-8c41-40f1-bbef-7e68692eec66	4
1233575	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	772d0184-8c41-40f1-bbef-7e68692eec66	4
1233575	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	SY	772d0184-8c41-40f1-bbef-7e68692eec66	4
1233575	APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	772d0184-8c41-40f1-bbef-7e68692eec66	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83059-0044-1	83059004401	1 BOTTLE in 1 PACKAGE (83059-0044-1) / 12 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-09-02	No	No	Current