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 177 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Nighttime Cold and Cough	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	KinderFarms, LLC	40904eb3-723c-4ddc-8a0e-5ae5ef74c259	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	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