Sorbugen

Product NDC: 52083-660
11-digit product format: 520830660
Labeler code: 52083
Product ID: 52083-660_796f9d98-f855-437f-9bca-bb322fa5b063
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, glycerol guaiacolate
Dosage form: SYRUP
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-08
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 15; 150 mg/7.5mL; mg/7.5mL
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: 2026-12-31
Current FDA listing: Yes

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52083-660-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52083-660-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52083-660-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52083-660-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52083-660-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52083-660-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52083-660-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52083-660-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Sorbugen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/7.5mL
GUAIFENESIN	150 mg/7.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996520	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
a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-660-16	2025-11-18	C162847	48780-1	2cef2736-ab86-d83d-e063-dadaa90ab31f	SORBUGEN ® NR
52083-660-16	2025-01-30	C162847	48780-1	2cef2736-ab86-d83d-e063-dadaa90ab31f	SORBUGEN ® NR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-660-16	Sorbugen	480 mL in 1 BOTTLE	SYRUP	480		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-660-16	ML - Milliliter	52083-660	b5276731-56be-48f8-b688-1537491875bf	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-660	SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]	6	Current NDC, Legacy NDC, 1 package rows	20221029_a8f2a2d7-0360-45a8-9635-c852f4a7d7ba.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 42 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CHAIN DRUG MARKETING ASSOCIATION INC	7d1b3418-85a8-4ca0-bca7-261b2b58032a	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROAT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy, Inc.	bfc38500-5706-0d03-e053-2995a90a5c72	2026-03-26	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS HEALTH CORP	2baa0861-dbef-7910-e063-6394a90a117e	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL	CVS Pharmacy, Inc.	c17d5ba7-3302-7931-e053-2a95a90a5a6c	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy, Inc.	c17b8f17-95f6-37e4-e053-2995a90a411a	2026-03-26	Warnings	Exact identifier application number: M012
Ultra concentrated Daytime/ Nighttime Severe Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL	CVS PHARMACY, INC	24cedaec-06a6-8fde-e063-6394a90a3d7a	2026-03-26	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23079537-1c06-1373-e063-6394a90a37d2	2026-03-26	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS MENTHOL SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f2fa8c-071f-50ab-e063-6394a90a4a4a	2026-03-26	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3618ccf0-1f30-42e0-bb50-bfa45cf2b583	2026-03-26	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion Night	PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	87231460-8b45-b995-e053-2a91aa0a6c43	2026-03-26	Warnings	Exact identifier application number: M012
VICKS CHILDRENS COUGH CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	f1d67797-c806-261d-e053-2a95a90a3c15	2026-03-26	Warnings	Exact identifier application number: M012
childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	HyVee Inc	686f43ea-4296-4eee-b762-9a9e68344340	2026-03-26	Warnings	Exact identifier application number: M012
Tussin DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59d3a486-97c2-4e60-90e2-1b5bfa7638c7	2026-03-26	Warnings	Exact identifier application number: M012
flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Meijer Distribution Inc	1a853e47-21a2-40e1-9e64-290af4843b13	2026-03-25	Warnings	Exact identifier application number: M012
cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	HyVee Inc	c4dcc427-aeec-4a26-80f3-02a4b227a520	2026-03-25	Warnings	Exact identifier application number: M012
Walgreens Lavender Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	327a1a00-852d-2756-e063-6394a90a5e29	2026-03-25	Warnings	Exact identifier application number: M012
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	2d56ddcd-3cc8-51eb-e063-6394a90ae745	2026-03-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TWIN MED LLC	7b000478-649d-4511-b3e0-eea6995b9784	2026-03-25	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f32457-23bf-d8a8-e063-6294a90a1e0d	2026-03-25	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY SUGAR-FREE	Medical Group Care LLC	f4a9ba87-c2a1-2de0-e053-2a95a90ada4c	2026-03-25	Warnings	Exact identifier application number: M012

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	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	7
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	7
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	7
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	7
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-660-16	52083066016	480 mL in 1 BOTTLE (52083-660-16)	480 ml	2014-10-08	0000-00-00	No	No	Current