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		2026-10-15

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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	2cbf27b6-217c-46d8-89c9-e46f3668f002	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d86d53cd-75ce-4c40-83cb-ada9b77a76f6	2026-07-17	Warnings	Exact identifier application number: M012
LEADER Multi Symptom Flu Relief Daytime Max Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	2212cf9e-6944-4922-b5b5-1373cf10b2e1	2026-07-16	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	CVS PHARMACY	06756130-1608-4ae6-9772-95a4549853a1	2026-07-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Old East Main Co.	7855033e-6a12-4cd8-b0a2-c5d69018d117	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: M012
Oxymetazoline Hydrochloride 12-Hour	OXYMETAZOLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	34a79f8b-32b7-48db-a895-c942cc795292	2026-07-16	Warnings	Exact identifier application number: M012
LoHist D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	93c9ad4f-3376-48c2-8276-0375663acd01	2026-07-16	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	522e1e7f-98ed-c475-e063-6294a90a622c	2026-07-16	Warnings	Exact identifier application number: M012
LEADER MS Flu Relief Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d	2026-07-16	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	1bf4cd96-5800-434d-a0dc-e84c759ebb33	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	Walgreens	2ace231a-94c4-479d-bb26-454bd07b207b	2026-07-16	Warnings	Exact identifier application number: M012
LEADER No Drip	ALLERGY SINUS NASAL MIST	CARDINAL HEALTH 110, LLC. DBA LEADER	e7b2c1c1-6250-4af3-b131-22aced2b23d5	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amerisource Bergen	639a59b7-ccff-485e-a232-38b680827229	2026-07-16	Warnings	Exact identifier application number: M012
Equate Nighttime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WALMART INC.	30470a01-4d42-44c6-a017-d68bb74cdef7	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93fe6d-ee21-e323-e063-6394a90a61bf	2026-07-15	Warnings	Exact identifier application number: M012
Pentrexcilina Daytime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b7b3c15a-bb28-5c25-e053-2a95a90ad3b1	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93c815-63c7-bfe0-e063-6394a90ab4a5	2026-07-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	5fa848ef-35ee-4e05-8ff2-781d034cf6ac	2026-07-14	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	0fad61d8-4393-47ec-9ff6-7df5be761f5b	2026-07-14	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Rite Aid Corporation	211c4273-3b2c-4169-b9c6-7a87903e77cd	2026-07-13	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