NAFASOLINA

Product NDC: 12539-146
11-digit product format: 125390146
Labeler code: 12539
Product ID: 12539-146_463c40c9-6e49-e804-e063-6394a90a3db8
Type: HUMAN OTC DRUG
Nonproprietary name: Naphazoline hydrochloride
Dosage form: SOLUTION/ DROPS
Route: NASAL
Labeler: Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-20
Substance: NAPHAZOLINE HYDROCHLORIDE
Active strength: 50 mg/100mL
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: NAFASOLINA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	50 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MZ1131787D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046602	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
30cade3d-208f-8594-e063-6394a90ad2a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
e18001c8-33ae-5f66-9cdc-a39724bd4573	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12539-146-01	NAFASOLINA	14.7868 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	14.7868		2
12539-146-02	NAFASOLINA	1 in 1 CARTON	SOLUTION/ DROPS	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12539-146	NAFASOLINA (NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DORAL PHARMAMEDICS INC DBA AG MARIN PHARMACEUTICALS]	1	Current NDC, 2 package rows	20250322_30cade3d-208f-8594-e063-6394a90ad2a0.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 74 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Cherry Cough Drops	MENTHOL	Kroger	a2e1d1f5-9b19-1704-e053-2a95a90abb51	2025-12-17	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	HEB	3a30a427-6ab4-24ae-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MZ1131787D	NAPHAZOLINE HYDROCHLORIDE	550-99-2	NAPHAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046602	naphazoline HCl 0.05 % Nasal Solution	PSN	30cade3d-208f-8594-e063-6394a90ad2a0	2
1046602	naphazoline hydrochloride 0.5 MG/ML Nasal Solution	SCD	30cade3d-208f-8594-e063-6394a90ad2a0	2
1046602	naphazoline hydrochloride 0.05 % Nasal Solution	SY	30cade3d-208f-8594-e063-6394a90ad2a0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
12539-146-01	12539014601	14.7868 mL in 1 BOTTLE, DROPPER	14.7868 ml				Historical
12539-146-02	12539014602	1 BOTTLE, DROPPER in 1 CARTON (12539-146-02) / 14.7868 mL in 1 BOTTLE, DROPPER (12539-146-01)		2025-03-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naphazoline hydrochloride 0.05%	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals \| DEXTRUM LABORATORIES INC.	2025-12-18	HUMAN OTC DRUG LABEL	2