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		2026-10-23

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 92 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	c296efd0-5030-4a26-a9b0-e66423d995dc	2025-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Max Maximum Strength Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates, LLC	f7ebe482-cb22-4517-8463-3432cf60071d	2025-10-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Max Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates, LLC	787bff76-0ee2-4e7e-b908-876e4a3e3bfc	2025-10-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Trader Joe's Company	647dadae-f37a-8399-e053-2991aa0aedb3	2025-10-31	Warnings	Exact identifier application number: M012
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40416ff5-06e1-97dd-e063-6394a90a2046	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	44feee2f-25bc-48d4-8e13-db1d9daaaa90	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b3d02c91-8f79-4eb4-a378-1072474c572c	2025-10-30	Warnings	Exact identifier application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	2025-10-30	Warnings	Exact identifier application number: M012
Endal	TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR	Poly Pharmaceuticals, Inc.	fc5401e2-ed65-72e7-e053-6294a90a81f3	2025-10-30	Warnings	Exact identifier application number: M012
daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	c7cef266-46fc-49ab-a2e7-54fc56298659	2025-10-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	SAFEWAY	013b94a1-26c7-4371-981a-d1b9d7fd1c98	2025-10-29	Warnings	Exact identifier application number: M012
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Exact identifier application number: M012
AXIM DayTime - Night Time 72 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	de9eb2d5-ba51-4637-e053-2995a90a0451	2025-10-29	Warnings	Exact identifier application number: M012
Dollar General Vapor Steam	CAMPHOR (SYNTHETIC)	DOLGENCORP, LLC	86d0f3ac-1359-c2f9-e053-2a91aa0a35d0	2025-10-29	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d628b09-c257-4369-8ddb-47554d83c0d8	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Wal-Mart Stores,Inc.,	a748d5ab-901c-47bb-8437-997542ecebfe	2025-10-28	Warnings	Exact identifier application number: M012
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	WAL-MART STORES,INC.	68a68574-0fcb-4569-be57-d9aee5f62bea	2025-10-28	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