Triponel

Product NDC: 54859-514
11-digit product format: 548590514
Labeler code: 54859
Product ID: 54859-514_474619be-162e-c769-e063-6394a90ac561
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Pseufoephedrine HCl, Triprolidine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Llorens Pharmaceutical International Division, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength: 15; 30; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-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-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-514-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-514-16	`9bebd1f3094a…`	`5416666fcb17…`

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
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL
TRIPROLIDINE HYDROCHLORIDE	30 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
6V9V2RYJ8N	Internal UNII lookup
YAN7R5L890	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e9a8deb4-0595-4f0f-ac15-f936f15aca88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54859-514-16	2020-12-23	C162847	48780-1	9d75b9d0-d471-f424-e053-dadaa90a57ce	Llorens-Triponel 514
54859-514-16	2020-01-31	C162847	48780-1	9d75b9d0-d471-f424-e053-dadaa90a57ce	Llorens-Triponel 514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-514-16	Triponel	474 mL in 1 BOTTLE	LIQUID	474		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-514-16	ML - Milliliter	54859-514	8315ea32-8fe0-4b23-bb75-9790aa7acdeb	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-514	TRIPONEL (DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20241225_e9a8deb4-0595-4f0f-ac15-f936f15aca88.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 133 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	b790a91c-33be-4bc3-bdeb-eae6f366f085	2024-12-05	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola Ag	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola Ag	8b2d5c0f-509e-447d-b071-d73c4785f120	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	8ae0e21a-44a0-4a2c-9880-54eeeaea07ea	2024-12-05	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	6d82469b-d51c-4824-9830-6c1874ad4fe4	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola Ag	e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	a535717d-ba55-45e9-9fc3-711b5d7dbf57	2024-12-05	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola Ag	4330ee8d-0b37-4a93-886b-5fc6e6598da7	2024-12-05	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORP	9de99931-31ef-79e2-e053-2a95a90a98ad	2024-12-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	3ef6d155-b95b-4b30-87a8-8ed811b1520f	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b2b16d-c767-2945-e053-2995a90a4834	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	fa9b2748-0474-4a39-a2b8-bb6f0678c1d1	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a9640e09-369c-3c55-e053-2a95a90aebd5	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c7-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	cbb179c8-31fb-4a3a-9f23-4024350f8b7f	2024-12-03	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a96431a0-b05d-4812-e053-2a95a90a5af6	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	aa0d6762-b803-4630-8f74-780b7ea9acff	2024-12-03	Warnings	Exact identifier application number: M012
Cold plus Head Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c5-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	898eb1c7-395a-4845-9d0a-719fc78d86b7	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	7854c1fd-b5fc-477d-a79e-ff006ebf6fe5	2024-12-03	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
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-514-16	54859051416	474 mL in 1 BOTTLE (54859-514-16)	474 ml	2018-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Triponel 514	Llorens Pharmaceutical International Division, Inc.	2025-12-31	HUMAN OTC DRUG LABEL	5