DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Product NDC: 69729-020
11-digit product format: 697290020
Labeler code: 69729
Product ID: 69729-020_5d203e0a-2498-6041-e063-6294a90a885b
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form: SYRUP
Route: ORAL
Labeler: OPMX LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-02-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 300 mg/5mL; mg/5mL
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	69729-020		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-020	69729-020-04	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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 HYDROBROMIDE and GUAIFENESIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/5mL
GUAIFENESIN	300 mg/5mL

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	Histiacil NF Pentrexicilina NF Brosolvan
2024-04-02	Histiacil NF Pentrexicilina NF Brosolvan
2024-01-30	Histiacil NF Pentrexicilina NF Brosolvan
2024-01-30	Histiacil NF Pentrexicilina NF Brosolvan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-020-04	DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	118 mL in 1 BOTTLE	SYRUP	118		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-020	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC]	7	Current NDC, Legacy NDC, 1 package rows	20250516_826c2f47-00a6-4060-a7ad-1ef26ccfddd1.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 145 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
TheraCare Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	d6e789c7-a55a-dc9a-e053-2a95a90a2bdb	2024-10-29	Warnings	Exact identifier application number: M012
Careone daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	American Sales Company	31187c98-6706-4962-91f6-022a390cda39	2024-10-28	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	0100f86e-257f-4197-9849-3c4429cdf0f2	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	PHARMACY VALUE ALLIANCE LLC	46bf124a-a44f-4066-b936-852d46da8f40	2024-10-28	Warnings	Exact identifier application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	25a26577-a9f8-49cb-9d75-d8c471e4aaf6	2024-10-28	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e	2024-10-28	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	d38537c6-9553-4e93-a83e-11ed48c955ab	2024-10-28	Warnings	Exact identifier application number: M012
Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	2b3a1997-f382-4843-a44b-d80d1ad21a90	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Tussin Cough Long Acting	DEXTROMETHORPHAN HBR	Chain Drug Consortium, LLC	0e393287-5bb8-458b-98c4-55fa16674d06	2024-10-28	Warnings	Exact identifier application number: M012
daytime cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1740ccfc-6e68-46f4-a1ba-48fe092f0aa0	2024-10-28	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
1117394	dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral Solution	PSN	826c2f47-00a6-4060-a7ad-1ef26ccfddd1	7
1117394	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution	SCD	826c2f47-00a6-4060-a7ad-1ef26ccfddd1	7
1117394	dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral Solution	SY	826c2f47-00a6-4060-a7ad-1ef26ccfddd1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-020-04	69729002004	118 mL in 1 BOTTLE (69729-020-04)	118 ml	2021-02-01	0000-00-00	No	No	Current