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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	00689aa5-ed39-4c9a-92b8-105d2c0e2e15	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	9aca1a68-893c-4770-8a48-d5d678058253	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	d26b5143-aa07-4114-a6ba-4f503aadd46f	2026-05-27	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	37533188-8c91-428b-a796-c5afd9e4959f	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	8252cdec-b668-4450-b045-e093479ab542	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Nighttime Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	27f9d2db-38ce-41d2-8f1a-0eb171600274	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Sore Throat	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	b37b786e-0cce-419d-94ed-3b64a1eb1201	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	a43d59f9-3a6c-4a7c-b98d-b86d6035f716	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Relief Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	5700ef26-ffa6-480a-bf36-bd5111799e9b	2026-05-27	Warnings	Exact identifier application number: M012
Air Power	GUAIFENESIN	Schwabe North America, Inc	5cdefc7a-6242-4681-88a3-04422a1d48d3	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	adb658c8-db8d-4db6-80c8-e0f2de88a2de	2026-05-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	c71427d4-707f-411f-8bd4-133517a9992b	2026-05-26	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CVS PHARMACY, INC	643e929d-9e62-4260-91ee-e88a184dd7cd	2026-05-26	Warnings	Exact identifier application number: M012
TopCare Day Time Nite Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	c00ff684-acaf-4fbe-bc74-7e48751b927d	2026-05-26	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PE	PHENYLEPHRINE	Cabinet Health P.B.C.	4e75da23-35f2-431c-92cb-c2c4cb3f09f1	2026-05-26	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	13492631-d5de-4562-a201-664f7d3591de	2026-05-26	Warnings	Exact identifier application number: M012
Sinufrin Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	52a2e5f9-e0a2-02f7-e063-6294a90a3ae9	2026-05-25	Warnings	Exact identifier application number: M012
Cough Suppressant Adult	DEXTROMETHORPHAN HYDROBROMIDE	Rugby Laboratories	47b713bd-4c1e-f44a-e063-6294a90a63d3	2026-05-25	Warnings	Exact identifier application number: M012
ClorRelief	CHLORPHENIRAMINE MALEATE	FERRER MEDICAL INNOVATIONS LLC	db729011-f72f-5911-e053-2a95a90a68bf	2026-05-22	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	74ff4f0d-7952-4b74-b1b2-5a2beab91f7c	2026-05-22	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