Equate Nasal

Product NDC: 49035-648
11-digit product format: 490350648
Labeler code: 49035
Product ID: 49035-648_814cdc0e-c8a0-4e15-a862-cae5a59d028f
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Wal-Mart Stores Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-07-24
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1 g/100mL
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-648-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-648-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-648-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-648-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-648-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Equate Nasal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	1 g/100mL

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
95ef1819-edc3-4dda-8514-85b61538cc72	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
49035-648-10	2025-03-19	C162847	48780-1	2cef2736-76ff-d83d-e063-dadaa90ab31f	Wal-Mart Nasal Spray Drug Facts
49035-648-10	2025-01-30	C162847	48780-1	2cef2736-76ff-d83d-e063-dadaa90ab31f	Wal-Mart Nasal Spray Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49035-648-10	Equate Nasal	1 in 1 CARTON	SPRAY	1		4
49035-648-10	Equate Nasal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-648-10	ML - Milliliter	49035-648	36ce4bc6-7b9b-4414-9f09-5417782cfb0b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-648	EQUATE NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]	4	Current NDC, Legacy NDC, 2 package rows	20240926_95ef1819-edc3-4dda-8514-85b61538cc72.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 61 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c1fae6c7-bbac-1320-e053-2a95a90aac5a	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	f4c60ca1-ba59-4a92-84a5-6ba65faa56ab	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	cec51eab-cce3-4965-a14e-a46d953050c4	2026-01-08	Warnings	Exact identifier application number: M012
VanaCof 2	CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE	GM Pharmaceuticals, INC	0c7c6756-abb2-c10c-e063-6394a90a9863	2026-01-08	Warnings	Exact identifier application number: M012
VANACOF XP Cough / Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	GM Pharmaceuticals, INC	0b3a8cc1-a49f-e1e5-e063-6394a90a1c06	2026-01-08	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	INVAHEALTH INC	e4e4004f-77e3-569d-e053-2a95a90a73fe	2026-01-08	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	868ac65a-63e2-46ac-b87d-66b289086756	2026-01-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	0324195f-506d-4747-990e-ad44e2a117d9	2026-01-07	Warnings	Exact identifier application number: M012
Sambrosa Night	DOXYLAMINE SUCCINATE	Sambrosa Care, Inc.	acdc8740-6231-d1e8-e053-2995a90a3b8d	2026-01-07	Warnings	Exact identifier application number: M012
VAPOREX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	DLC Laboratories, Inc.	971943b1-4199-4f75-9d2d-61242d346b5f	2026-01-07	Warnings	Exact identifier application number: M012
BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DLC Laboratories, Inc.	2e612c62-9bbb-45f2-a253-aa2bfaeaac70	2026-01-07	Warnings	Exact identifier application number: M012
Earths Care Chest Rub	CAMPHOR, EUCALYPTUS OI, MENTHOL	DLC Laboratories, Inc	2424f5d5-1772-96f1-e063-6294a90a89ee	2026-01-07	Warnings	Exact identifier application number: M012
Bactimicina Vapor Rub	VAPOR RUB	DLC Laboratories, Inc.	176b617a-faf6-7893-e063-6294a90a046b	2026-01-07	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, PHENYLEPHRINE HCL	Family Dollar Services Inc	0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2	2026-01-07	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b225e897-5728-4519-b727-c0f361c75976	2026-01-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	80b218f7-66bb-4e15-a0dc-ec9b6af1b056	2026-01-07	Warnings	Exact identifier application number: M012
tussin cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	13618054-d0c5-4190-b626-e7e91b855738	2026-01-06	Warnings	Exact identifier application number: M012
Berkley and Jensen Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	c15b97a8-968f-4d38-905e-863e9fd16ce6	2026-01-06	Warnings	Exact identifier application number: M012
Complete Allergy Medicine	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	c0f5c8ca-b187-40bf-9245-6a29f1c32c97	2026-01-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	c5776b1e-9f72-4a6a-9961-8ac8e05b3249	2026-01-06	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	95ef1819-edc3-4dda-8514-85b61538cc72	4
1087043	phenylephrine hydrochloride 10 MG/ML Nasal Spray	SCD	95ef1819-edc3-4dda-8514-85b61538cc72	4
1087043	phenylephrine hydrochloride 1 % Nasal Spray	SY	95ef1819-edc3-4dda-8514-85b61538cc72	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-648-10	49035064810	1 BOTTLE, SPRAY in 1 CARTON (49035-648-10) / 30 mL in 1 BOTTLE, SPRAY	2002-07-24	0000-00-00	No	No	Current