Sinus Headache PEMaximum Strength Non-Drowsy

Product NDC: 69168-270
11-digit product format: 691680270
Labeler code: 69168
Product ID: 69168-270_5614edd7-fae9-4261-aa48-bd393f771caa
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-22
Marketing end: 2027-10-31
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable	ASPIRIN	Better Living Brands, LLC	7afce7b4-c86a-43f7-83cf-15ebffba2f35	2026-07-28	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	03b871e8-3e14-4ed8-a978-45129255b272	2026-07-27	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Rite Aid Corporation	17d27771-a112-474f-9a58-29af0d7e1af3	2026-07-27	Warnings	Exact identifier application number: M013
Children Pain Relief Gummy	ACETAMINOPHEN CHILDREN GUMMY	Gummy USA	5513db67-f023-7f47-e063-6294a90a2757	2026-07-24	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fdb7331a-d029-8b2a-e053-6294a90adfcd	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	5ada044e-50e8-4874-ac04-df5f1f9e735d	2026-07-24	Warnings	Exact identifier application number: M013
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	a63727c3-64d8-4ae9-8da3-974cae6beed2	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e4a2566e-48ec-4602-87e3-143398d15f33	2026-07-24	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Exact identifier application number: M013
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	ce58105b-f010-47af-8f31-6dd4ce4e9cba	2026-07-22	Warnings	Exact identifier application number: M013
Vicks PainQuil PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	0ad7b313-5d72-4cc0-97f0-1a30770350af	2026-07-22	Warnings	Exact identifier application number: M013

Additional Listing Data#

Finished product: Yes
Brand name base: Sinus Headache PEMaximum Strength Non-Drowsy
Brand name suffix: Maximum Strength Non-Drowsy

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	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
1046378	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
b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	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
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69168-270-95	2020-03-13	C162847	48780-1	9d75b9d0-f02b-f424-e053-dadaa90a57ce	Drug Facts
69168-270-95	2020-01-31	C162847	48780-1	9d75b9d0-f02b-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-270-95	Sinus Headache PEMaximum Strength Non-DrowsyMaximum Strength Non-Drowsy	18 in 1 BLISTER PACK	TABLET	18		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-270	SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	6	Current NDC, Legacy NDC, 1 package rows	20231114_b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	7
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	7
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-270-95	69168027095	18 TABLET in 1 BLISTER PACK (69168-270-95)	18 tablet	2014-12-22	2027-10-31	No	No	Current