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 114 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Sinus Max Clear and Cool	ACETAMINOPHEN AND GUAIFENESIN	RB Health (US) LLC	37de813a-54b7-672a-e063-6294a90a374e	2025-06-18	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a1aeb41-a8fa-4116-8068-e11acd608e58	2025-06-18	Warnings	Exact identifier application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED	Lil' Drug Store Products, Inc.	37c768f5-dabd-22d0-e063-6394a90af9e5	2025-06-17	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART Childrens Allergy Chewable	DIPHENHYDRAMINE HCL	DISCOUNT DRUG MART	51de95da-e8e8-48f0-9fa4-6191aa4a247b	2025-06-16	Warnings	Exact identifier application number: M012
Halls Cherry	MENTHOL	Mondelez Global LLC	5f4af8e8-8550-45c7-a199-694efac9e7be	2025-06-16	Warnings	Exact identifier application number: M012
Halls Honey Lemon	MENTHOL	Mondelez Global LLC	25eaae85-d516-40da-a472-70736ea2b75d	2025-06-16	Warnings	Exact identifier application number: M012
Halls Cherry	MENTHOL	Mondelez Global LLC	bad89968-22a7-4287-a57c-9e6206e574fe	2025-06-16	Warnings	Exact identifier application number: M012
Herbal Throat Drops	LEMON MINT HERBAL	Meijer, Inc.	37dd58ad-95d1-568c-e063-6394a90a9433	2025-06-16	Warnings	Exact identifier application number: M012
topcare childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	40a6a7e3-6ec9-4005-9406-9d5b044b3c21	2025-06-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Sinus Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Target Corporation	23f50b88-52c3-2029-e063-6394a90ac73e	2025-06-14	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Berries Flavor 25ct	PECTIN	Dollar General Corporation	c53c19a9-5984-4b08-ae46-a53dc8bb7d74	2025-06-13	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry Flavor 25ct	PECTIN	Dollar General Corporation	d82034ca-b7fd-48c8-ab4a-8e1e56418324	2025-06-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Belleview Biosciences	1db57d86-39f0-f8ca-e063-6394a90a6397	2025-06-12	Warnings	Exact identifier application number: M012
TARGET Cold and Cough and Nighttime Value Pack	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,	TARGET CORPORATION	ce536313-7265-405c-88b7-f45e62781da5	2025-06-11	Warnings	Exact identifier application number: M012
Capron Max	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3756812b-f128-8946-e063-6294a90a59ba	2025-06-11	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	60311ca3-8544-417e-aa29-e9f65c6692ba	2025-06-11	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65d2815-6932-123c-e053-2a95a90a2cf9	2025-06-10	Warnings	Exact identifier application number: M012
Cold Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	0cc66c6c-db26-4bb2-a97d-c4106210d70c	2025-06-10	Warnings	Exact identifier application number: M012
Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	75a9c736-bc7e-4b7f-84ea-9474a37508ec	2025-06-10	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	8877bb8d-479f-4968-8033-5c269d449a46	2025-06-10	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