Triponel

Product NDC: 54859-508
11-digit product format: 548590508
Labeler code: 54859
Product ID: 54859-508_47461d04-60e6-bfde-e063-6394a90aaeec
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength: 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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: Triponel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/5mL
TRIPROLIDINE HYDROCHLORIDE	1.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
YAN7R5L890	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2268058	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
cc774d33-96ce-4992-ad30-3cb03b0d119d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-508-16	Triponel	474 mL in 1 BOTTLE	LIQUID	474		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-508-16	ML - Milliliter	54859-508	ce99e05a-3a93-4deb-99f7-b8b893d62bba	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-508	TRIPONEL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	2	Current NDC, Legacy NDC, 1 package rows	20241222_cc774d33-96ce-4992-ad30-3cb03b0d119d.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 143 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier application number: M012
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	Warnings	Exact identifier application number: M012
Severe Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	d40d6fd1-3f84-40ae-ab7e-04569eb41617	2024-10-30	Warnings	Exact identifier application number: M012
equaline nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	4e0c6ad6-81ef-4b0e-b2eb-44256faf7358	2024-10-30	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fbe2c0-7749-4c8a-e063-6394a90a7c6e	2024-10-30	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	130e68d1-9048-49c1-beee-490eecaed2d9	2024-10-30	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	02f3e739-3153-412f-b2cd-6f01dcd5875b	2024-10-30	Warnings	Exact identifier application number: M012
HealthWise Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	25a19d3e-37b3-50d5-e063-6394a90a97d1	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23a03-6110-f595-e063-6394a90a70fe	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23e5e-302a-7b7f-e063-6294a90a0463	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Pharmadel LLC	25a26adf-fd90-bf57-e063-6294a90a4073	2024-10-29	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	e82dac83-2910-44dc-e053-2995a90a38e1	2024-10-29	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2268058	dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG in 5 mL Oral Solution	PSN	cc774d33-96ce-4992-ad30-3cb03b0d119d	3
2268058	dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 1 MG/ML / triprolidine hydrochloride 0.25 MG/ML Oral Solution	SCD	cc774d33-96ce-4992-ad30-3cb03b0d119d	3
2268058	dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 5 ML Oral Solution	SY	cc774d33-96ce-4992-ad30-3cb03b0d119d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-508-16	54859050816	474 mL in 1 BOTTLE (54859-508-16)	474 ml	2019-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Triponel 508	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-31	HUMAN OTC DRUG LABEL	3