Nasal Decongestant PE

Product NDC: 69168-272
11-digit product format: 691680272
Labeler code: 69168
Product ID: 69168-272_d6f9b26d-57c2-492c-aafd-baf2f1ffd3e3
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine 10 mg
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-23
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Nasal Decongestant PE
Brand name suffix: Maximum Strength Non-Drowsy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049182	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
7aef00df-816a-4ea2-a2ad-beed66dd2fe4	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#

Effective, Related label table
Effective	Related label
2020-03-13	Drug Facts
2020-03-13	Drug Facts
2020-01-31	Drug Facts
2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-272-17	Nasal Decongestant PEMaximum Strength Non-Drowsy	300 in 1 BOTTLE	TABLET	300	10
69168-272-82	Nasal Decongestant PEMaximum Strength Non-Drowsy	90 in 1 BOTTLE	TABLET	90	10
69168-272-93	Nasal Decongestant PEMaximum Strength Non-Drowsy	1 in 1 CARTON	TABLET	1	10
69168-272-93	Nasal Decongestant PEMaximum Strength Non-Drowsy	24 in 1 BLISTER PACK	TABLET	24	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-272	NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]	9	Current NDC, Legacy NDC, 4 package rows	20231114_7aef00df-816a-4ea2-a2ad-beed66dd2fe4.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 82 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Cold and Cough	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	75862805-2cfe-fb45-e053-2991aa0a1403	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5172dc01-4e7f-3307-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	20ae92d9-fbc6-5b7a-e063-6294a90a15c3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51c44970-06e5-082e-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	54236151-37db-0b5a-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	52542774-fd05-640c-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dca689-e4a0-5526-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f2d18f6-935f-9215-e053-2a91aa0aedd3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6fb28fa1-ebbb-64bf-e053-2991aa0a1de4	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5213ca7f-5a78-6471-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f7ba256-ed14-5fe0-e053-2a91aa0aacc1	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	6f7bf92d-4aaf-86e0-e053-2991aa0a2d91	2025-12-04	Warnings	Exact identifier application number: M012
Afrin NoDrip Allergy Sinus Night	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	b023a571-7e54-7c63-e053-2a95a90a0f78	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	Bayer HealthCare LLC.	b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3231869-8ddf-9d17-e053-2995a90ae6d5	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Multi Symptom Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ae7cf41e-b618-d6bb-e053-2a95a90a6692	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Allergy Sinus Nasal	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	c2d903bf-5c51-82d7-e053-2995a90aea49	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold, Cough and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	351d3c5c-05c8-921a-e063-6394a90abef9	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Bayer HealthCare LLC.	de95d2dd-e766-f7ec-e053-2995a90afc5f	2025-12-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	10
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-272-17	69168027217	300 TABLET in 1 BOTTLE (69168-272-17)	300 tablet	2021-06-16	0000-00-00	No	No	Current
69168-272-82	69168027282	90 TABLET in 1 BOTTLE (69168-272-82)	90 tablet	2022-05-18	0000-00-00	No	No	Current
69168-272-93	69168027293	1 BLISTER PACK in 1 CARTON (69168-272-93) / 24 TABLET in 1 BLISTER PACK	1 blister pack	2014-12-23	0000-00-00	No	No	Current