Miclara DM

Product NDC: 70868-740
Requested package NDC: 70868-740-16
11-digit product format: 708680740
Labeler code: 70868
Product ID: 70868-740_d67cf0cc-7c79-8640-e053-2995a90a7b1e
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Key Therapeutics
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-09-01
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength: 20 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70868-740	70868-740-16	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70868-740-16	2023-07-28	C162847	48780-1	d6a99b39-94f3-a426-e053-dadaa90af4c2	Miclara DM
70868-740-16	2022-02-04	C162847	48780-1	d6a99b39-94f3-a426-e053-dadaa90af4c2	Miclara DM
70868-740-16	2022-01-28	C162847	48780-1	d6a99b39-94f3-a426-e053-dadaa90af4c2	Miclara DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70868-740-16	Miclara DM	473 mL in 1 BOTTLE	LIQUID	473		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70868-740	MICLARA DM (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) LIQUID [KEY THERAPEUTICS]	3	Legacy NDC, 1 package rows	20220205_c86e012b-17d0-4ffd-b815-9c07771bfaf1.zip

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
1492052	dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 5 mL Oral Solution	PSN	c86e012b-17d0-4ffd-b815-9c07771bfaf1	3
1492052	dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML / triprolidine hydrochloride 0.5 MG/ML Oral Solution	SCD	c86e012b-17d0-4ffd-b815-9c07771bfaf1	3
1492052	dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	c86e012b-17d0-4ffd-b815-9c07771bfaf1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70868-740-16	70868074016	473 mL in 1 BOTTLE (70868-740-16)	473 ml	2020-09-01	0000-00-00	No	No	Current