DEXTROMETHORPHAN HBR, GUAIFENESIN

Product NDC: 69729-781
11-digit product format: 697290781
Labeler code: 69729
Product ID: 69729-781_155b8919-8006-caa9-e063-6394a90a876b
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HBR, GUAIFENESIN
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: OPMX LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-18
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 400 mg/1; mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 · 6 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
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-781-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-781-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-781-02	`bd6a592717d7…`	`303034d00443…`

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: DEXTROMETHORPHAN HBR, GUAIFENESIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1
GUAIFENESIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1661740	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
9a16e7f3-78aa-0b01-e053-2a95a90ab19c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-04-02	Pentrexcilina Expectorant & Cough Suppressant
2024-01-30	Pentrexcilina Expectorant & Cough Suppressant
2022-04-12	Pentrexcilina Expectorant & Cough Suppressant
2022-01-28	Pentrexcilina Expectorant & Cough Suppressant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-781-02	DEXTROMETHORPHAN HBR, GUAIFENESIN	20 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	20		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-781	DEXTROMETHORPHAN HBR, GUAIFENESIN CAPSULE, LIQUID FILLED [OPMX LLC]	7	Current NDC, Legacy NDC, 1 package rows	20240406_9a16e7f3-78aa-0b01-e053-2a95a90ab19c.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 162 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Cold and Cough Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Safeway, Inc.	cbbec807-f882-4c6a-b1cd-c7fd5ce70cad	2024-05-15	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742	2024-05-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	f658a03b-6fc2-4b63-b3ab-7e886fbf20b4	2024-05-15	Warnings	Exact identifier application number: M012
AXIV DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	18704e66-ee8f-315d-e063-6294a90a5282	2024-05-14	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	187622dc-ecde-181d-e063-6294a90a4e8f	2024-05-14	Warnings	Exact identifier application number: M012
Lemon Mint Drops	MENTHOL	Target Corporation Inc.	1876df19-398a-23d8-e063-6394a90ae7e8	2024-05-14	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway, Inc.	6c952c81-c8b6-4e74-abd8-781f6f44736b	2024-05-14	Warnings	Exact identifier application number: M012
Pain and Sinus Reliever	ACETAMINOPHEN AND PHENYLEPHRINE	JHK DBA American Safety & First Aid	249373c6-f56f-4bd3-9cef-98b7ee73457d	2024-05-14	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	fea71cb9-e044-4729-ad26-1db0cdb9dd11	2024-05-14	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	2024-05-14	Warnings	Exact identifier application number: M012
Day Time Cold and Flu Relief non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	cc450f89-a156-48e0-82ae-19782f13c2ca	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	a8df5c04-0f92-4013-b3e5-2b45009a7b8d	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Safeway, Inc.	f762600a-f4b1-4869-a04b-8431c3d8a3e3	2024-05-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	ef0cd436-5e81-47a7-92d6-58495283ab28	2024-05-13	Warnings	Exact identifier application number: M012
Tussin Cough Sugar Free	DEXTROMETHORPHAN HBR GUAIFENESIN	P & L Development, LLC	7ed2fe86-3346-4308-a9b6-6a264f879b02	2024-05-09	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	10106c90-f2f0-508e-e063-6294a90a544b	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1661740	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Capsule	PSN	9a16e7f3-78aa-0b01-e053-2a95a90ab19c	7
1661740	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Capsule	SCD	9a16e7f3-78aa-0b01-e053-2a95a90ab19c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-781-02	69729078102	20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-781-02)	2019-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentrexcilina Expectorant & Cough Suppressant	OPMX LLC \| MEDGEL PRIVATE LIMITED	2024-04-05	HUMAN OTC DRUG LABEL	7