SUPRESS A

Product NDC: 52083-057
11-digit product format: 520830057
Labeler code: 52083
Product ID: 52083-057_5247bb80-1971-424b-8bf1-1f76465d6bac
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: SYRUP
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-08-01
Substance: DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1; 10; 5 mg/mL; mg/mL; mg/mL
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: 2027-12-31
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	52083-057-01	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	52083-057-01	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	52083-057-01	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	52083-057-01	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	52083-057-01	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	52083-057-01	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	52083-057-01	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	52083-057-01	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: SUPRESS A
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	1 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BPA9UT29BS	Internal UNII lookup
9D2RTI9KYH	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
1303797	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
f0bec5f5-4d76-471e-9024-557eba848b93	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-11-07	SUPRESS A
2025-11-07	SUPRESS A
2025-01-30	SUPRESS A
2025-01-30	SUPRESS A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-057-01	SUPRESS A	30 mL in 1 BOTTLE, PLASTIC	SYRUP	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-057-01	ML - Milliliter	52083-057	c530a5e5-7702-4e1b-8ec2-0dc0a7431c7d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-057	SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]	2	Current NDC, Legacy NDC, 1 package rows	20171229_f0bec5f5-4d76-471e-9024-557eba848b93.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 165 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1303797	dexbrompheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 1 mL Oral Solution	PSN	f0bec5f5-4d76-471e-9024-557eba848b93	3
1303797	dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution	SCD	f0bec5f5-4d76-471e-9024-557eba848b93	3
1303797	dexbrompheniramine maleate 1 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 1 ML Oral Solution	SY	f0bec5f5-4d76-471e-9024-557eba848b93	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-057-01	52083005701	30 mL in 1 BOTTLE, PLASTIC (52083-057-01)	30 ml	2012-08-01	0000-00-00	No	No	Current