Rescon GG

Product NDC: 64543-044
11-digit product format: 645430044
Labeler code: 64543
Product ID: 64543-044_edfe66d3-63a8-100c-e053-2a95a90aba47
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Phenylephrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Capellon Pharmaceuticals, LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-01-01
Marketing end: 0000-00-00
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 100 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64543-044		D	Discontinued by firm	2026-10-16
excluded package	package	64543-044	64543-044-01	D	Discontinued by firm	2026-10-16
excluded package	package	64543-044	64543-044-04	D	Discontinued by firm	2026-10-16
excluded package	package	64543-044	64543-044-16	D	Discontinued by firm	2026-10-16

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64543-044-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64543-044-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64543-044-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64543-044-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64543-044-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64543-044-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64543-044-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64543-044-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64543-044-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64543-044-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64543-044-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64543-044-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64543-044-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64543-044-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64543-044-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64543-044-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64543-044-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64543-044-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64543-044-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64543-044-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64543-044-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64543-044-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64543-044-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64543-044-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64543-044-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64543-044-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64543-044-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64543-044-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64543-044-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64543-044-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64543-044-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64543-044-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64543-044-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64543-044-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64543-044-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64543-044-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64543-044-04	ML - Milliliter	64543-044	f9420574-d91e-4b9b-8379-dbb2a98b1b5c	1	2012-07-24
64543-044-16	ML - Milliliter	64543-044	bd647251-894a-4d1f-baef-a8a612da2d96	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64543-044-01	64543004401	25 mL in 1 BOTTLE (64543-044-01)	25 ml	1999-01-01	0000-00-00	Yes	No	Current
64543-044-04	64543004404	118 mL in 1 BOTTLE (64543-044-04)	118 ml	1999-01-01	0000-00-00	No	No	Current
64543-044-16	64543004416	473 mL in 1 BOTTLE (64543-044-16)	473 ml	1999-01-01	0000-00-00	No	No	Current