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: 2026-12-31

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 134 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	e07d880b-a12a-4e5e-94c0-bd36bcfe738c	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	bd0a3679-1f7c-4c41-e053-2995a90a8fcb	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	bd09e4f3-3211-8c08-e053-2a95a90a73f9	2024-12-03	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b373a3a8-68c4-0187-e053-2995a90aad62	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b281ec-fd42-963c-e053-2a95a90a4b71	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	b3366ad4-5ef4-eb70-e053-2995a90acf33	2024-12-03	Warnings	Exact identifier application number: M012
Meijer Medicated Chest Rub, 3.53 oz. Lavender	MENTHOL, CAMPHOR, EUCALYPTUS OIL	Meijer Distribution	22516f25-b8aa-7511-e063-6394a90a6125	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd9513-1a42-e990-e063-6294a90a57df	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	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