EB306 NASAL DECONGESTANT

Product NDC: 53304-0306
11-digit product format: 533040306
Labeler code: 53304
Product ID: 53304-0306_2b5ffa7e-257b-47b9-b8d4-4fc45d3453b1
Type: HUMAN OTC DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE
Dosage form: SPRAY
Route: NASAL
Labeler: EMINENCE BIOTECH CORPORATION LIMITED
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-11-01
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 22 mg/15mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53304-0306		I	Inactivated by FDA		2026-11-12
excluded package	package	53304-0306	53304-0306-1	I	Inactivated by FDA		2026-11-12

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53304-0306-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53304-0306-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53304-0306-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53304-0306-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53304-0306-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53304-0306-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53304-0306-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53304-0306-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53304-0306-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53304-0306-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53304-0306-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53304-0306-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53304-0306-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53304-0306-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53304-0306-1	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
53304-0306-1	2023-01-30	C162847	48780-1	f386c649-badb-0266-e053-dadaa90a7c1a	EB306 NASAL DECONGESTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53304-0306-1	EB306 NASAL DECONGESTANT	1 in 1 BOX	SPRAY	1		2
53304-0306-1	EB306 NASAL DECONGESTANT	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
AMARANTHUS VIRIDIS LEAF	INACTIVE INGREDIENT	7T0WZ76K1T	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
GAULTHERIA PROCUMBENS LEAF	INACTIVE INGREDIENT	2125M16OWN	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
PLATOSTOMA CHINENSIS WHOLE	INACTIVE INGREDIENT	FE70D062O9	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
PORK SIDE BACON, CURED FAT	INACTIVE INGREDIENT	6E710H379S	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53304-0306	EB306 NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2	Legacy NDC, 2 package rows	20180321_887562bf-1b9d-4980-8859-5d8d8a723994.zip

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
238996	phenylephrine HCl 0.125 % Nasal Spray	PSN	887562bf-1b9d-4980-8859-5d8d8a723994	2
238996	phenylephrine hydrochloride 1.25 MG/ML Nasal Spray	SCD	887562bf-1b9d-4980-8859-5d8d8a723994	2
238996	phenylephrine HCl 0.125 % Nasal Spray	SY	887562bf-1b9d-4980-8859-5d8d8a723994	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53304-0306-1	53304030601	1 BOTTLE, SPRAY in 1 BOX (53304-0306-1) > 15 mL in 1 BOTTLE, SPRAY	2012-11-01	0000-00-00	No	No	Current