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 136 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SanaTos Boost	DEXTROMETHORPHAN HBR	Pharmadel LLC	ae6a424f-f3f0-3f6c-e053-2995a90a972d	2024-11-18	Warnings	Exact identifier application number: M012
SanaTos Turbo Max Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	d56a071c-a747-5397-e053-2995a90aad8b	2024-11-18	Warnings	Exact identifier application number: M012
equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a24021a0-ef68-4bce-ba53-d262d1025cc0	2024-11-17	Warnings	Exact identifier application number: M012
Cold and Cough DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	4d5f93c1-7752-4948-ba58-c4385cfc24c8	2024-11-17	Warnings	Exact identifier application number: M012
Good Sense Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	8a87104f-94a4-4585-afd5-d610eea32e39	2024-11-17	Warnings	Exact identifier application number: M012
equate childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4	2024-11-17	Warnings	Exact identifier application number: M012
foster and thrive childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services LLC	1eac715b-351c-4b47-8d1d-6e921813c1a4	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	298d2796-5ae5-4346-b6d2-2ced2dd29dc3	2024-11-15	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief night time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	f721b393-9ad5-4fc6-a2c5-bd89e58caf16	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2	2024-11-15	Warnings	Exact identifier application number: M012
Rompe Pecho EX	GUAIFENESIN	Efficient Laboratories Inc	89ea23a5-0da7-407e-83d9-77a0b562f3af	2024-11-14	Warnings	Exact identifier application number: M012
basic care daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	ceb342da-ff6d-4c19-9f78-0033d028075e	2024-11-14	Warnings	Exact identifier application number: M012
Topcare Nite Time Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	efb8e0e2-0795-4f4a-8ca6-955f33bee143	2024-11-14	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal four	PHENYLEPHRINE HYDROCHLORIDE	Amerisource Bergen	a3d637dc-d957-458c-8a75-f948601a31aa	2024-11-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Exact identifier application number: M012
dg health tussin	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	6f9b8267-1e0b-430b-8e44-06408ae82ea4	2024-11-13	Warnings	Exact identifier application number: M012
Walgreens Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walgreens	b60e2cf9-11ec-469e-e053-2a95a90a712a	2024-11-13	Warnings	Exact identifier application number: M012
Kroger Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Kroger Company	69333774-3cf4-384d-e053-2a91aa0a48b3	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	H. E. Butt Grocery Company	6403fe3d-d82b-f4d5-e053-2991aa0ac7d6	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	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