FDA.reportPublic FDA data

Dibromm Cold and Allergy

Product NDC
83324-156
11-digit product format
833240156
Labeler code
83324
Product ID
83324-156_f0e372d9-760a-45cf-925c-8014ab8b490a
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-31
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 5 mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Dibromm Cold and Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053258Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c830b18b-4427-4530-9bc7-85c2735080d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-156-04Dibromm Cold and Allergy1 in 1 BOXLIQUID12
83324-156-04Dibromm Cold and Allergy118 mL in 1 BOTTLE, PLASTICLIQUID1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-156-04ML - Milliliter83324-156d0d44c82-aaed-463e-8200-2fa19976efdc12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-156DIBROMM COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Current NDC, 2 package rows20240731_c830b18b-4427-4530-9bc7-85c2735080d2.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 65 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2de803-900d-02f4-e063-6394a90a84cc2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMON SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307f3a7-f6e7-8a5d-e063-6394a90ab7eb2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2e8fbe-c1c3-79b1-e063-6394a90a4d732025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2dfcc3-e599-3102-e063-6394a90ad54a2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2ead3c-b4d5-ee8f-e063-6294a90a3c392025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f45499-bf14-03e4-e063-6394a90a535c2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3ddcc-9d4e-f1b1-e063-6294a90ac86f2025-12-29WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a5551-4989-d8fe-e063-6394a90aeabf2025-12-29WarningsExact identifier
application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough DropsMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2acaa-2cc8-a999-e063-6294a90a15ce2025-12-29WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINLlorens Pharmaceutical International Division, Inc.77c16288-68c4-476c-995f-86f5056632702025-12-29WarningsExact identifier
application number: M012
Tusnel DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.fe457e6d-422d-496c-bcb9-33594f3c42ff2025-12-29WarningsExact identifier
application number: M012
Tusnel DiabeticDEXTROMETHORPHAN, GUAIFENESINLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION66b3c094-809e-4d2c-bc15-46563de685cb2025-12-29WarningsExact identifier
application number: M012
FortifyMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M012
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNc830b18b-4427-4530-9bc7-85c2735080d22
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDc830b18b-4427-4530-9bc7-85c2735080d22
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSYc830b18b-4427-4530-9bc7-85c2735080d22
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYc830b18b-4427-4530-9bc7-85c2735080d22
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYc830b18b-4427-4530-9bc7-85c2735080d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-156-04833240156041 BOTTLE, PLASTIC in 1 BOX (83324-156-04) / 118 mL in 1 BOTTLE, PLASTIC2024-07-31NoNoCurrent