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…`

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 1 of 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	464534ee-15f8-3af8-e063-6394a90a3f18	2026-08-24	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-20	Warnings	Exact identifier application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	4d94968b-ada3-4344-8563-cba7fc491d74	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus chest congestion	GUAIFENESIN	CVS PHARMACY	bec04049-03b2-4465-9cf5-0ad2ef8014ef	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY, INC	fe12f3bd-3237-42d1-aec5-c831b9637175	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9	2026-08-19	Warnings	Exact identifier application number: M012
CVS Long Acting Cough	DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	31a7c0e2-af1c-45dd-8a93-e0879cae6005	2026-08-19	Warnings	Exact identifier application number: M012
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	b3baf939-a9fd-47ac-9bc7-68435e32ea1e	2026-08-19	Warnings	Exact identifier application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	5151127a-4d09-413a-a08b-f76fb77e1188	2026-08-19	Warnings	Exact identifier application number: M012
CVS DT and NT Combo Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	360c8c62-0945-4031-b291-d40c4270b940	2026-08-19	Warnings	Exact identifier application number: M012
equate childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	24758ab0-ba08-4b4a-9861-449612bdb89c	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus plus Chest Congestion	GUAIFENESIN	CVS PHARMACY	3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	CVS	7dc30e46-e289-40fc-b217-b123fee5daee	2026-08-19	Warnings	Exact identifier application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY	4490a7e1-d5b9-459c-8751-c24486807981	2026-08-19	Warnings	Exact identifier application number: M012
CVS DayTime and NightTime Value Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	4c813cd5-2c97-4fc3-926c-1a0396551a31	2026-08-19	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