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		2026-10-27

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 162 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime Honey	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0fa3d-d6b2-272a-e063-6394a90a1205	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	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