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 9 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	212acd54-6ff0-446a-a3bb-3b40e1279711	2026-08-13	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Caramel Apple Cough Drops	MENTHOL	Bestco	58eee9b4-d696-995f-e063-6294a90a5db0	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Pumpkin Spice Cough Drops	MENTHOL	Bestco	58ef6619-9087-5f41-e063-6294a90a7da6	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Bourbon Honey Cough Drops	MENTHOL	Bestco	58efdf29-83ea-03b9-e063-6294a90ad306	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	af35c833-316a-4d21-bd3a-9b71558cadbf	2026-08-12	Warnings	Exact identifier application number: M012
Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c	2026-08-11	Warnings	Exact identifier application number: M012
Best Health Maple Spice Cough Drops	MENTHOL	Bestco	58cfdacb-c713-220f-e063-6394a90acbfc	2026-08-11	Warnings	Exact identifier application number: M012
7 Select Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	7-ELEVEN	f9475972-0cbb-45c5-9e49-09569f1665a7	2026-08-11	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3	2026-08-10	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