GUAIFENESIN, DEXTROMETHORPHAN HBR

Product NDC: 69729-783
11-digit product format: 697290783
Labeler code: 69729
Product ID: 69729-783_5c3f7648-b025-9de5-e063-6394a90a7b6b
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN, DEXTROMETHORPHAN HBR
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: OPMX LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-18
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 400; 20 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: 2027-12-31
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 · 10 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
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69729-783-02	`834df4deac94…`	`adcc014656a3…`
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	69729-783-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-783-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
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	69729-783-02	`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	69729-783-02	`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: GUAIFENESIN, DEXTROMETHORPHAN HBR
Listing expiration: 2027-12-31

Active Ingredients#

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

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
2024-05-17	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-05-17	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-01-30	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-01-30	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-09-20	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-09-20	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-01-28	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-01-28	TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-783-02	GUAIFENESIN, DEXTROMETHORPHAN HBR	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		5
69729-783-02	GUAIFENESIN, DEXTROMETHORPHAN HBR	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-783	GUAIFENESIN, DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED [OPMX LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240518_9a246099-72b5-2efc-e053-2a95a90aafbc.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 154 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	efcf2edd-21a3-45f9-e053-2995a90a3865	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff65505-8846-35c2-e053-2a95a90a6b79	2024-10-07	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	eff0fdfe-695a-4e62-e053-2a95a90ab50f	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff1a70f-fa71-52b2-e053-2995a90a038c	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Menthol Cough Drops	HONEY LEMON MENTHOL	Topco Associates LLC	f5be283b-524d-26af-e053-2995a90a3972	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff16ba3-7e30-aa93-e053-2995a90a64cb	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Rompe Pecho SF Flu SF Flu	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06eac696-e8f6-ac50-e063-6394a90a2ed6	2024-10-07	Warnings	Exact identifier application number: M012
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Exact identifier application number: M012
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Exact identifier application number: M012
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

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	9a246099-72b5-2efc-e053-2a95a90aafbc	5
1661740	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Capsule	SCD	9a246099-72b5-2efc-e053-2a95a90aafbc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-783-02	69729078302	2 BLISTER PACK in 1 CARTON (69729-783-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2019-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)	OPMX LLC	2026-09-24	HUMAN OTC DRUG LABEL	6