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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	AmerisourceBergen Drug Corp	79cefd46-bd19-4a1d-9cb1-e85ff0f12494	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Cardinal Health	8397e1b9-e83e-4c6a-b858-1663c2365840	2024-12-18	Warnings	Exact identifier application number: M012
GNP Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	AmerisourceBergen Drug Corp	63932e68-b09d-4500-bc1d-cfb2c267df1c	2024-12-18	Warnings	Exact identifier application number: M012
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Exact identifier application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	TOPCO ASSOCIATES LLC	b6c0362f-86ca-4f08-ba53-800c6df2c025	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	10cad9a7-1223-470c-9027-807891217d40	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Rugby Laboratories	5da36516-9f94-49cb-9421-0c310abcd116	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	THE KROGER CO	430c6604-93a7-4df6-a657-ba438aa61425	2024-12-18	Warnings	Exact identifier application number: M012
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	Warnings	Exact identifier application number: M012
Dollar General Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Dolgencorp, LLC	718f08d2-3757-4f3e-915e-3e4982ad090f	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	e4610d53-4459-43a0-9351-f0ac8586df60	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	Valu Merch	5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6	2024-12-17	Warnings	Exact identifier application number: M012
Chestrub	CAMPHOR MENTHOL EUCALYPTUS OIL	Delta Brands Inc	8e6f731f-c16a-41b2-9786-0cab588cfc8e	2024-12-17	Warnings	Exact identifier application number: M012
Mentholatum Nighttime Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	5539ae74-9723-480d-b35f-0a6644bf54ad	2024-12-17	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