Nasal Decongestant PE

Product NDC: 63868-144
11-digit product format: 638680144
Labeler code: 63868
Product ID: 63868-144_d534021e-9167-4966-bd79-d13ee792282b
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-14
Marketing end: 2027-11-30
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63868-144	63868-144-74	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Non-Drowsy Maximum Strength

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
bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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	SPL version
63868-144-19	Nasal Decongestant PENon-Drowsy Maximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	18
63868-144-19	Nasal Decongestant PENon-Drowsy Maximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	18
63868-144-37	Nasal Decongestant PENon-Drowsy Maximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2	18
63868-144-37	Nasal Decongestant PENon-Drowsy Maximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	18
63868-144-74	Nasal Decongestant PENon-Drowsy Maximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	18
63868-144-74	Nasal Decongestant PENon-Drowsy Maximum Strength	4 in 1 CARTON	TABLET, FILM COATED	4	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-144-19	EA - Each	63868-144	b5927e77-46ef-4f74-8f8d-c3a856dd9833	1	2022-09-12
63868-144-37	EA - Each	63868-144	27b2cccd-bdd5-4cd2-aac3-04c6f8c4c9ef	1	2022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-144	NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	17	Current NDC, Legacy NDC, 6 package rows	20250130_bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d.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 55 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	Warnings	Exact identifier application number: M012
Seacall Nasal Spray.	NASAL SPRAY	Guangdong Quadrant Ecological Technology Co., Ltd.	1f12618b-7461-fb47-e063-6294a90af753	2026-01-23	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf7d210-102c-4053-81f6-67116de6cf7b	2026-01-23	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	44f9255b-0bf9-4573-ac9c-410acb515bc2	2026-01-23	Warnings	Exact identifier application number: M012
Daytime cold and flu non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Meijer Distribution Inc	29caa3a7-7fe6-4134-a9b0-49bdb9280ca7	2026-01-23	Warnings	Exact identifier application number: M012
good neighbor pharmacy night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7	2026-01-23	Warnings	Exact identifier application number: M012
RAYO ACTIVE ICE	MENTHOL, CAMPHOR	Quimicas Handal de Centroamerica SA de CV	09e4a36b-020a-c5b1-e063-6394a90a3e31	2026-01-22	Warnings	Exact identifier application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc.	f466fc0e-3384-4884-832e-99bf1fdcf899	2026-01-21	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR GUAIFENESIN	Strategic Sourcing Services LLC	84750bfb-9e94-40a3-b731-21799f5e4fd1	2026-01-20	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Amerisource Bergen	0b58990f-2246-408e-9365-51f56bb6766c	2026-01-20	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	a8460fc9-2d08-4e5f-8dd3-5135ecda5923	2026-01-20	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Family Dollar Services Inc	0a651316-623e-41eb-ab3a-641f5d807425	2026-01-20	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu	WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	Walgreens	579c47c8-6366-4785-9680-d3986ce9641d	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold	WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD	Walgreens	dd61c9d3-0b70-450e-9525-282710b383cc	2026-01-19	Warnings	Exact identifier application number: M012
Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	48bf7422-38ef-d4b4-e063-6294a90aa3ab	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	fc670515-a820-4ea7-8786-8ae710798b31	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	WALGREENS	9dece7b1-00b1-2499-e053-2a95a90a0be3	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	2dba2bec-e0e3-4910-89c5-ebc093e05bec	2026-01-19	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	bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	18
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-144-19	63868014419	1 BLISTER PACK in 1 CARTON (63868-144-19) / 18 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2005-01-14	2027-07-31	No	No	Current
63868-144-37	63868014437	2 BLISTER PACK in 1 CARTON (63868-144-37) / 18 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-01-14	2027-11-30	No	No	Current
63868-144-74	63868014474	4 BLISTER PACK in 1 CARTON (63868-144-74) > 18 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	2005-01-14	2022-03-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice 44-453-Delisted	CHAIN DRUG MARKETING ASSOCIATION INC \| LNK International, Inc.	2026-01-12	HUMAN OTC DRUG LABEL	18