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

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: 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

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 40 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique at Home APAP Extra Strength	ACETAMINOPHEN 500 MG	Unifirst First Aid Corporation	b56b4110-fb8f-e5a0-e053-2995a90a0ad3	2025-09-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	64c642b7-ef83-44b7-a014-6fa248dff3ba	2025-09-08	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE	BJWC (Berkley & Jensen / BJ's)	2f473f1f-7cf3-2af5-e063-6394a90aaa17	2025-09-01	Warnings	Exact identifier application number: M013
foster and thrive rapid release pain relief	ACETAMINOPHEN	Strategic Sourcing Services LLC	d2130173-b107-4ae6-a1f7-6db467da3820	2025-08-30	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	e1d4f562-433c-4344-9b77-1a7c731d1be5	2025-08-29	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Safeway	0e0a73f9-8c18-41fd-812e-8be20287e77a	2025-08-26	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Sixarp, LLC	2e20be17-2b6c-1a07-e063-6394a90acdd3	2025-08-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Exact identifier application number: M013
Medique Medi Seltzer	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Unifirst First Aid Corporation	528da9d9-2a52-4c16-b7b2-61b3eee1abea	2025-08-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Publix Super Markets Inc	6b691dc1-09e4-46d3-b199-8917e42848a6	2025-08-19	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	P & L Development, LLC	59eb14a5-40b0-4331-beb5-7166e6cdf411	2025-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	Warnings	Exact identifier application number: M013

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