4 Way

Product NDC: 0067-2086
11-digit product format: 000672086
Labeler code: 0067
Product ID: 0067-2086_43684c76-26b5-24c9-e063-6294a90a9b46
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-01
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/mL
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0067-2086		I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0067-2086	0067-2086-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: 4 Way
Brand name suffix: Fast Acting
Listing expiration: 2026-12-31

Active Ingredients#

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

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
1087043	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
a8fc41c7-4425-41b8-b1c6-eb22ac054734	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
0067-2086-01	2025-07-29	C162847	48780-1	3b156c62-2e25-fb37-e063-e6dba90a4e07	Drug Facts
0067-2086-01	2025-07-29	C162847	48780-1	3b156c62-2e25-fb37-e063-e6dba90a4e07	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-2086-01	4 WayFast Acting	29.6 mL in 1 BOTTLE, SPRAY	SPRAY	29.6		13
0067-2086-01	4 WayFast Acting	1 in 1 CARTON	SPRAY	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-2086-01	ML - Milliliter	0067-2086	c086c908-628d-4743-84e6-3d43fe57b914	1	2012-07-24
0067-2086-05	ML - Milliliter	0067-2086	69981360-0504-4153-a7f4-eb82aa864002	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-2086	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240912_a8fc41c7-4425-41b8-b1c6-eb22ac054734.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
1087043	phenylephrine HCl 1 % Nasal Spray	PSN	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13
1087043	phenylephrine hydrochloride 10 MG/ML Nasal Spray	SCD	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13
1087043	phenylephrine hydrochloride 1 % Nasal Spray	SY	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-2086-01	00067208601	1 BOTTLE, SPRAY in 1 CARTON (0067-2086-01) / 29.6 mL in 1 BOTTLE, SPRAY	2010-01-01	0000-00-00	No	No	Current