Guaifenesin STRAWBERRY-BANANA FLAVOR

Product NDC: 71800-059
11-digit product format: 718000059
Labeler code: 71800
Product ID: 71800-059_37de006a-e717-a4e5-e063-6394a90abd8b
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: LIQUID
Route: ORAL
Labeler: Innovida Pharmaeutique Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-06-16
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 STRAWBERRY-BANANA FLAVOR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
310604	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
1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71800-059-19	Guaifenesin STRAWBERRY-BANANA FLAVOR	119 mL in 1 TUBE	LIQUID	119		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71800-059-19	ML - Milliliter	71800-059	d3fa3ffd-d057-44a7-b7b8-f8d657a3803c	1	2026-04-20

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 164 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Tesalon Jarabe Adulto	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN USP, PHENYLEPHRINE HCL	OPMX LLC	231c6455-4198-feec-e063-6394a90a8541	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
Mucus Relief Cough and Congestion Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN	KinderFarms, LLC	5b123501-cc51-42cd-b7b7-65833f44166b	2024-10-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	KinderFarms, LLC	57a130db-2b27-4e09-b0bb-179d4ef52c15	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
Nighttime Cold and Cough	DIPHENHYDRAMINE HCL	KinderFarms, LLC	bfcedca7-f758-4654-822a-5c431906f34d	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
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71800-059-19	71800005919	119 mL in 1 TUBE (71800-059-19)	119 ml	2025-06-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin STRAWBERRY-BANANA FLAVOR - Innovida Pharmaeutique Corporation	Innovida Pharmaeutique Corporation	2025-06-18	HUMAN OTC DRUG LABEL	1