Guaifenesin 200mg

Product NDC: 69517-148
11-digit product format: 695170148
Labeler code: 69517
Product ID: 69517-148_d6aa4904-e177-47a3-e053-2a95a90a6139
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: HEALTHLIFE OF USA LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-01-28
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 200 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69517-148		I	Inactivated by FDA		2026-10-12
excluded package	package	69517-148	69517-148-03	I	Inactivated by FDA		2026-10-12

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69517-148-03	Guaifenesin 200mg	300 in 1 BOTTLE	TABLET	300		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69517-148	GUAIFENESIN 200MG (GUAIFENESIN) TABLET [HEALTHLIFE OF USA LLC]	2	Legacy NDC, 1 package rows	20231021_d6aa1493-bc22-a318-e053-2995a90a6381.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197741	guaiFENesin 200 MG Oral Tablet	PSN	d6aa1493-bc22-a318-e053-2995a90a6381	4
197741	guaifenesin 200 MG Oral Tablet	SCD	d6aa1493-bc22-a318-e053-2995a90a6381	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69517-148-03	69517014803	300 TABLET in 1 BOTTLE (69517-148-03)	300 tablet	2022-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin 200mg	HEALTHLIFE OF USA LLC \| HHH PHARMA USA, LLC dba/HHH Pharmaceuticals \| Elysium Pharmaceuticals Ltd	2026-10-03	HUMAN OTC DRUG LABEL	5