Childrens Giltuss EX Expectorant

Product NDC: 65852-016
11-digit product format: 658520016
Labeler code: 65852
Product ID: 65852-016_3f8d7d47-f14d-888c-e063-6394a90a5cdd
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Dextrum Laboratories Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-22
Substance: GUAIFENESIN
Active strength: 200 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: Childrens Giltuss EX Expectorant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	200 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
310625	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
3f8d7d47-f14c-888c-e063-6394a90a5cdd	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
65852-016-04	Childrens Giltuss EX Expectorant	1 in 1 CARTON	SOLUTION	1		1
65852-016-04	Childrens Giltuss EX Expectorant	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		1

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 160 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	Warnings	Exact identifier application number: M012
Family Wellness Effervescent Cold Relief Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Family Dollar Services, Inc.	4e13511b-fbb5-2523-e054-00144ff88e88	2024-07-03	Warnings	Exact identifier application number: M012
Nighttime Cherry Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	TARGET CORPORATION	1c3f6cbf-a00d-45b9-e063-6394a90a797c	2024-07-02	Warnings	Exact identifier application number: M012
Cold Terminator Cold Relief	PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Wildman Business Group	e8538d9c-f9ba-40b1-b60f-f57921f39b64	2024-07-01	Warnings	Exact identifier application number: M012
Nighttime Severe Honey Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1c02e465-8750-a088-e063-6394a90a8efb	2024-06-29	Warnings	Exact identifier application number: M012
ACTIDOM DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	0166322e-7dbb-4658-a5c5-1d0525bb7655	2024-06-28	Warnings	Exact identifier application number: M012
ACTINEL DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ACTIPHARMA, LLC	16660d82-524b-42ca-8581-48237caa13b2	2024-06-28	Warnings	Exact identifier application number: M012
PurgenLabs Acetaminophen	ACTAMINOPHEN	Advanced Rx LLC	915c4608-af1b-4119-8291-4ce9fd701d76	2024-06-28	Warnings	Exact identifier application number: M012
Daytime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	1bc90b2f-612c-e977-e063-6294a90a40b4	2024-06-26	Warnings	Exact identifier application number: M012
Halls Mentholyptus	MENTHOL	Mondelez Global LLC	f5292c5b-5608-4e13-afc2-4f3d7133da88	2024-06-25	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	75638f29-7f2a-46b0-b8a0-e87bc7d6eba1	2024-06-25	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	TARGET CORPORATION	130ca5f1-2951-ec6f-e063-6394a90a754f	2024-06-24	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	TARGET CORPORATION	08fd1513-30ab-15da-e063-6394a90ab57d	2024-06-21	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	0c0caa59-0637-bc33-e063-6294a90ae244	2024-06-21	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	de401eb4-3282-4298-8a51-15d268253464	2024-06-21	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	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
310625	guaiFENesin 200 MG in 5 mL Oral Solution	PSN	3f8d7d47-f14c-888c-e063-6394a90a5cdd	1
310625	guaifenesin 40 MG/ML Oral Solution	SCD	3f8d7d47-f14c-888c-e063-6394a90a5cdd	1
310625	guaifenesin 200 MG per 5 ML Oral Solution	SY	3f8d7d47-f14c-888c-e063-6394a90a5cdd	1
310625	guaifenesin 400 MG per 10 ML Oral Solution	SY	3f8d7d47-f14c-888c-e063-6394a90a5cdd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
65852-016-04	65852001604	1 BOTTLE, PLASTIC in 1 CARTON (65852-016-04) / 118 mL in 1 BOTTLE, PLASTIC	2020-06-22	No	No	Current