Neo-Synephrine Maximum

Product NDC: 0225-0810
11-digit product format: 002250810
Labeler code: 0225
Product ID: 0225-0810_0a49488a-841e-7937-e063-6294a90aeac8
Type: HUMAN OTC DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE
Dosage form: SPRAY
Route: NASAL
Labeler: BF ASCHER AND CO INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-07-01
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

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: Neo-Synephrine Maximum
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087043	Internal RxNorm lookup
1234569	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
ab8682a4-1f66-6709-e053-2995a90a8b4a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0225-0810-47	Neo-Synephrine Maximum	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0225-0810-47	ML - Milliliter	0225-0810	0395c5b1-1952-4ac7-9e67-e87115e1b6ce	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0225-0810	NEO-SYNEPHRINE MAXIMUM (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [BF ASCHER AND CO INC]	3	Current NDC, Legacy NDC, 1 package rows	20231117_ab8682a4-1f66-6709-e053-2995a90a8b4a.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 167 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Cough Long-Acting	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	75bc7827-4439-e6a8-a65c-7154d5592e58	2024-03-17	Warnings	Exact identifier application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	2024-03-17	Warnings	Exact identifier application number: M012
ANTIGRIP Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	12f20aba-f991-bd82-e063-6294a90a4aac	2024-03-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	WALGREENS	d3053f80-aece-eb50-e053-2a95a90a5945	2024-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL	WALGREENS	d315bc95-1b46-75df-e053-2a95a90a6c66	2024-03-15	Warnings	Exact identifier application number: M012
MAR-COF CG Expectorant	CODEINE PHOSPHATE AND GUAIFENESIN	Marnel Pharmaceuticals, LLC	60a41229-b125-43d8-b2b4-0bf40feed764	2024-03-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	97aa0b90-1230-4143-b5d3-18b96a6b7b4f	2024-03-15	Warnings	Exact identifier application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	036162c9-f5a6-418e-bd5e-ebd72097d27d	2024-03-15	Warnings	Exact identifier application number: M012
Bronkaid Max	EPHEDRINE SULFATE	Foundation Consumer Healthcare LLC	9a0b792a-caee-41f6-9400-922a5ebd592f	2024-03-14	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2	2024-03-12	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	A-S Medication Solutions	ffcae882-0b19-4219-bbee-a175c63d79c8	2024-03-11	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	18dcede2-5a38-40fa-93fe-48acdd6a7cf1	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	d4ce06aa-776f-45e4-a1a6-9cf13797048f	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	14e38ef0-a5e7-4df7-824f-f27bef664d25	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	68d3e88a-d1be-410b-92a1-863903b3aa61	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	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
1234569	Neo-Synephrine 1 % Nasal Spray	PSN	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1087043	phenylephrine HCl 1 % Nasal Spray	PSN	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1234569	phenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine]	SBD	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1087043	phenylephrine hydrochloride 10 MG/ML Nasal Spray	SCD	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1234569	Neo-Synephrine 1 % Nasal Spray	SY	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1234569	Neo-Synephrine 10 MG/ML Nasal Spray	SY	ab8682a4-1f66-6709-e053-2995a90a8b4a	3
1087043	phenylephrine hydrochloride 1 % Nasal Spray	SY	ab8682a4-1f66-6709-e053-2995a90a8b4a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0225-0810-47	00225081047	15 mL in 1 BOTTLE, SPRAY (0225-0810-47)	15 ml	2020-07-01	0000-00-00	No	No	Current