Tussi Pres B

Product NDC: 52083-237
Requested package NDC: 52083-237-01
11-digit product format: 520830237
Labeler code: 52083
Product ID: 52083-237_d5487434-8196-490e-90f9-ce09ce43c65d
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: KRAMER NOVIS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-03-29
Substance: DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 20; 4; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 · 8 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	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: Tussi Pres B
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/5mL
BROMPHENIRAMINE MALEATE	4 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
IXA7C9ZN03	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148155	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
d0afa44c-3acf-42a5-9889-4e9c10225256	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
52083-237-01	2025-11-18	TUSSI PRES- B
52083-237-04	2025-11-18	TUSSI PRES- B
52083-237-16	2025-11-18	TUSSI PRES- B
52083-237-01	2025-01-30	TUSSI PRES- B
52083-237-04	2025-01-30	TUSSI PRES- B
52083-237-16	2025-01-30	TUSSI PRES- B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52083-237-01	Tussi Pres B	30 mL in 1 BOTTLE	SYRUP	30	5
52083-237-04	Tussi Pres B	120 mL in 1 BOTTLE	SYRUP	120	5
52083-237-16	Tussi Pres B	480 mL in 1 BOTTLE	SYRUP	480	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-237-04	ML - Milliliter	52083-237	8a64cdb9-9a9f-495c-b009-18c0f607fc7d	1	2012-07-24
52083-237-16	ML - Milliliter	52083-237	459d48b1-724f-43e0-9cfe-136520a619e5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-237	TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 3 package rows	20191106_d0afa44c-3acf-42a5-9889-4e9c10225256.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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Exact identifier application number: M012
Cough and Runny Nose Childrens Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	TOP CARE (Topco Associates LLC)	6f04bd51-093c-4624-aef3-0145ac387386	2026-06-01	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	694a3116-1b75-42cd-bbcf-d19831c2d796	2026-06-01	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	cf31538c-9eee-4c81-80cb-66eecabf0aff	2026-06-01	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	155e07b3-0a08-3be8-e063-6394a90a7635	2026-05-31	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Nighttime	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	156033ae-b16a-007b-e063-6294a90a7445	2026-05-31	Warnings	Exact identifier application number: M012
Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	ebf8c82d-a653-4c02-893b-61704901acbb	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Amerisource Bergen	934c7b91-3cba-47f0-8efa-77216f3f15c4	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Medicine	DIPHENHYDRAMINE HCL	COSTCO WHOLESALE CORPORATION	d9f03e11-d11f-43ee-8ed0-9e07d1058f66	2026-05-29	Warnings	Exact identifier application number: M012
Cold Childrens, Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d	2026-05-29	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	3598ac5b-29f9-f002-e063-6294a90a62cb	2026-05-28	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2026-05-28	Warnings	Exact identifier application number: M012
Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	a7ab2140-de09-158f-e053-2a95a90a25a0	2026-05-28	Warnings	Exact identifier application number: M012
Kids Multi Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	2d918ec8-3098-1d09-e063-6294a90a9e8f	2026-05-28	Warnings	Exact identifier application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Genexa Inc.	213fe898-dace-9a0f-e063-6394a90afd64	2026-05-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Lemon Flavor	MENTHOL	Medical Group Care LLC	556628ab-e233-92fe-e063-6394a90a0090	2026-05-28	Warnings	Exact identifier application number: M012
Sinus Decongestion PE	PHENYLEPHRINE HCL	Kroger Company	68eff734-177e-4999-9126-6b92bb204107	2026-05-28	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	ARMY AND AIR FORCE EXCHANGE SERVICE	ff39084f-ab2f-48ed-ac62-837f7fff2b65	2026-05-28	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Select Consumer Group LLC	52c5fda0-c358-72e8-e063-6394a90a3f68	2026-05-27	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	16637d54-8049-d3ce-e063-6394a90aafc9	2026-05-27	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
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148155	brompheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution	PSN	d0afa44c-3acf-42a5-9889-4e9c10225256	5
1148155	brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	d0afa44c-3acf-42a5-9889-4e9c10225256	5
1148155	brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution	SY	d0afa44c-3acf-42a5-9889-4e9c10225256	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-237-01	52083023701	30 mL in 1 BOTTLE (52083-237-01)	30 ml	2011-03-29	0000-00-00	No	No	Current