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: 2027-12-31
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: 2027-12-31

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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	DeMoulas Market Basket	e92d2f64-9690-42d3-b787-cafade3a8999	2023-12-29	Warnings	Exact identifier application number: M012
Cold and Sinus Maxium Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	6e5ca8e1-5a03-4e77-b385-d44387fb3bfc	2023-12-29	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat Maxium Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	d98029c0-ccd9-47e1-996f-c7786cd4ecca	2023-12-29	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	0f2be061-bd0a-4e62-b994-6d0768ea647a	2023-12-29	Warnings	Exact identifier application number: M012
Tussin CF Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	c19b9997-4037-48f3-b905-86da421a292d	2023-12-29	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier application number: M012
Father Johns Cough Medicine Plus	NASAL DECONGESTANT	Oakhurst Company	8b8aab0f-251b-6bd8-e053-2995a90ad748	2023-12-18	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Oakhurst Company	8b8a249d-55af-cc98-e053-2995a90a431d	2023-12-18	Warnings	Exact identifier application number: M012
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79d92d2-d73c-d44f-e053-2995a90a03d9	2023-12-15	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL TABLET	Lil' Drug Store Products, Inc.	e5339c39-1d66-b283-e053-2995a90a4317	2023-12-15	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Humco Holding Group, Inc	a7b0669f-8da1-5a44-e053-2995a90a84d9	2023-12-15	Warnings	Exact identifier application number: M012
Ephedrine Hydrochloride	EPHEDRINE HYDROCHLORIDE	Walgreen Company	bcb81dc1-d854-30c0-e053-2a95a90a9fc7	2023-12-14	Warnings	Exact identifier application number: M012
Allergy, Circle K	DIPHENHYDRAMINE HCL 25MG TABLET	Lil' Drug Store Products, Inc.	d1f370ac-e7f4-baf7-e053-2995a90a1e50	2023-12-14	Warnings	Exact identifier application number: M012
Circle K Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	a6a1e3d9-575c-4adf-beb6-c9719de55c67	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Sinus Severe, Circle K	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store products, Inc.	e78c456f-f62e-596d-e053-2995a90a2397	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Max Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79f1a92-d8ea-e3f9-e053-2a95a90a2d37	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	bcc1a001-4176-485d-aaf0-2037ca65c6b8	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2023-12-13	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline No Drip	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	0c006b1c-8ab2-4b9c-8738-e7001c1bb47d	2023-12-11	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