Dextromethorphan HBr and Guaifenesin

Product NDC: 50383-062
11-digit product format: 503830062
Labeler code: 50383
Product ID: 50383-062_c9b98014-38e5-4347-b26d-43c4c3aa7da1
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr and Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-03-07
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-062		I	Inactivated by FDA	2026-10-15
excluded package	package	50383-062	50383-062-06	I	Inactivated by FDA	2026-10-15
excluded package	package	50383-062	50383-062-07	I	Inactivated by FDA	2026-10-15
excluded package	package	50383-062	50383-062-11	I	Inactivated by FDA	2026-10-15
excluded package	package	50383-062	50383-062-12	I	Inactivated by FDA	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 2 · 75 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	50383-062-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-062-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-062-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-062-07	`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	50383-062-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-062-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-062-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-062-07	`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	50383-062-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-062-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-062-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-062-07	`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	50383-062-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-062-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-062-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-062-07	`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	50383-062-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-062-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-062-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-062-07	`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	50383-062-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-062-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-062-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-062-07	`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	50383-062-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-062-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-062-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-062-07	`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	50383-062-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-062-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-062-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-062-07	`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	50383-062-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-062-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-062-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-062-07	`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	50383-062-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-062-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-062-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-062-07	`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	50383-062-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-062-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-062-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-062-07	`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	50383-062-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-062-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-062-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-062-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50383-062-06	Drug Facts
50383-062-07	Drug Facts
50383-062-11	Drug Facts
50383-062-12	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-062-05	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-05	Dextromethorphan HBr and Guaifenesin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
50383-062-06	Dextromethorphan HBr and Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-062-07	Dextromethorphan HBr and Guaifenesin	10 in 1 CASE	SOLUTION	10	5
50383-062-07	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-10	Dextromethorphan HBr and Guaifenesin	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	5
50383-062-10	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-11	Dextromethorphan HBr and Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-062-12	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-12	Dextromethorphan HBr and Guaifenesin	10 in 1 CASE	SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-062-05	ML - Milliliter	50383-062	3b76b61d-6899-435b-8d7b-f22839e108c3	1	2013-03-03
50383-062-06	ML - Milliliter	50383-062	33711fd0-1dcd-49bd-96e0-872094c2444e	1	2013-04-01
50383-062-07	ML - Milliliter	50383-062	c141208d-32c2-42be-8255-dd4390799d58	1	2013-04-01
50383-062-10	ML - Milliliter	50383-062	60cbe226-4e0b-4d6e-886c-ca1d2e0e621b	1	2013-03-03
50383-062-11	ML - Milliliter	50383-062	374a31ec-bcfd-4172-9491-42fd98a7fbd1	1	2013-04-01
50383-062-12	ML - Milliliter	50383-062	a6540397-da10-4136-aaad-7a30c5d09a92	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-062	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [AKORN]	5	Legacy NDC, 10 package rows	20220309_ed74de02-852a-4dfe-8462-fa22044a2258.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	ed74de02-852a-4dfe-8462-fa22044a2258	5
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	ed74de02-852a-4dfe-8462-fa22044a2258	5
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	ed74de02-852a-4dfe-8462-fa22044a2258	5
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	ed74de02-852a-4dfe-8462-fa22044a2258	5
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	ed74de02-852a-4dfe-8462-fa22044a2258	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-062-05	50383006205	10 in 1 TRAY						Historical
50383-062-06	50383006206	4 TRAY in 1 CASE (50383-062-06) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-05) > 5 mL in 1 CUP, UNIT-DOSE	4 tray	2012-03-07	0000-00-00	No	No	Current
50383-062-07	50383006207	10 TRAY in 1 CASE (50383-062-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE	10 tray	2012-03-07	0000-00-00	No	No	Current
50383-062-10	50383006210	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
50383-062-11	50383006211	4 TRAY in 1 CASE (50383-062-11) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-10) > 10 mL in 1 CUP, UNIT-DOSE	4 tray	2012-03-07	0000-00-00	No	No	Current
50383-062-12	50383006212	10 TRAY in 1 CASE (50383-062-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE	10 tray	2012-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Akorn \| Akorn Operating Company LLC	2022-03-08	HUMAN OTC DRUG LABEL	5
Drug Facts	A-S Medication Solutions	2020-01-18	HUMAN OTC DRUG LABEL	6