Cough Out

Product NDC: 58593-255
11-digit product format: 585930255
Labeler code: 58593
Product ID: 58593-255_37db956a-258a-9804-e063-6394a90aa2b4
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Efficient Laboratories Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1997-07-01
Marketing end: 2026-10-31
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58593-255	58593-255-04	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Cough Out

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310604	Internal RxNorm lookup
1099024	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
fe4c3921-8d30-4cd6-ba90-9211b362a38a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58593-255-04	2020-02-16	Cough Out
58593-255-06	2020-02-16	Cough Out
58593-255-04	2020-01-31	Cough Out
58593-255-06	2020-01-31	Cough Out

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-255-04	Cough Out	118 mL in 1 BOTTLE	LIQUID	118		9
58593-255-06	Cough Out	178 mL in 1 BOTTLE	LIQUID	178		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-255	COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241016_fe4c3921-8d30-4cd6-ba90-9211b362a38a.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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	WAL-MART STORES INC	888bd90a-a059-4814-bd65-6b735ecfaf3a	2026-08-31	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime and Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	49a98411-aa5a-6de3-e063-6294a90a148f	2026-08-31	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	Sixarp, LLC	5a5a6917-9fb5-e6ca-e063-6394a90af9dc	2026-08-31	Warnings	Exact identifier application number: M012
Zicam Intense Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	d916f7ff-84b7-57ef-e053-2995a90a3efa	2026-08-31	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-31	Warnings	Exact identifier application number: M012
Dextromethorphan HBr	DEXTROMETHORPHAN HBR	BIONPHARMA INC.	5a5dde85-8785-8149-e063-6294a90a4d57	2026-08-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Sixarp, LLC	5a5e2458-bab0-4931-e063-6394a90ad606	2026-08-31	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF	DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL	Reckitt Benckiser LLC	8d670d91-9e22-45b9-b568-5b62c2133d32	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	Akron Pharma Inc.	3b023b91-e703-4599-9864-96d8c328b45c	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion	GUAIFENESIN	Akron Pharma Inc.	ac874a31-5556-4669-937f-dcb52aaecd8a	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	e0ce4287-bfa1-4413-97c8-4fe2e39bda36	2026-08-31	Warnings	Exact identifier application number: M012
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	24173e77-92ec-4a87-a471-d6867837c180	2026-08-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	69af44c2-390c-4223-889a-d5555aef5778	2026-08-28	Warnings	Exact identifier application number: M012
Tussin DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	432d4833-2eaf-4f7c-b6b4-41043a6b7e2a	2026-08-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M012
Multi-Symptom Allergy	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreen Company	5170c450-989d-44fa-ab38-86c78feae3b6	2026-08-28	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	54cbbc5f-908b-47b2-b37f-3646354d3568	2026-08-27	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Hyvee Inc	4e578c7a-88d4-e4cd-e063-6394a90aac44	2026-08-27	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
1099024	Cough Out 100 MG in 5 mL Oral Solution	PSN	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
1099024	guaifenesin 20 MG/ML Oral Solution [Cough Out]	SBD	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 20 MG/ML Oral Solution	SCD	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
1099024	Cough Out 100 MG per 5 ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
1099024	Cough Out 20 MG/ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	fe4c3921-8d30-4cd6-ba90-9211b362a38a	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-255-04	58593025504	118 mL in 1 BOTTLE (58593-255-04)	118 ml	1997-07-01	0000-00-00	No	No	Current
58593-255-06	58593025506	178 mL in 1 BOTTLE (58593-255-06)	178 ml	1997-07-01	2026-10-31	No	No	Current