FDA.reportPublic FDA data

Dimetapp

Product NDC
69536-355
11-digit product format
695360355
Labeler code
69536
Product ID
69536-355_17925cc1-55d4-5673-e063-6394a90aabcb
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
KIT
Labeler
Foundation Consumer Healthcare
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dimetapp
Brand name suffix
Cold and Cough and Nighttime Cold and Cough
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049884Internal RxNorm lookup
2683421Internal RxNorm lookup
2683422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
179259a9-231e-df03-e063-6294a90a145eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-315-04DimetappCold and Cough and Nighttime Cold and Cough1 in 1 CARTONSOLUTION2 mg in 10mL1
69536-315-04DimetappCold and Cough and Nighttime Cold and Cough118 mL in 1 BOTTLESOLUTION118 mL10 mg in 10mL1
69536-345-04DimetappCold and Cough and Nighttime Cold and Cough1 in 1 CARTONSOLUTION12.5 mg in 10mL1
69536-345-04DimetappCold and Cough and Nighttime Cold and Cough118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 10mL1
69536-355-08DimetappCold and Cough and Nighttime Cold and Cough1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-355DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER HEALTHCARE]1Current NDC, 5 package rows20240601_179259a9-231e-df03-e063-6294a90a145e.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 144 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
application number: M012
Premier Value Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC46bf124a-a44f-4066-b936-852d46da8f402024-10-28WarningsExact identifier
application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
application number: M012
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
application number: M012
Premier Value Tussin Cough Long ActingDEXTROMETHORPHAN HBRChain Drug Consortium, LLC0e393287-5bb8-458b-98c4-55fa16674d062024-10-28WarningsExact identifier
application number: M012
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact identifier
application number: M012
night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.d3bd0632-328c-4ad7-bb44-8383e1e51b8c2024-10-28WarningsExact identifier
application number: M012
Premier ValueDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC1ae3c6ac-1646-4c67-a9d5-9c383924b81a2024-10-28WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy1c341cf5-ac33-4a6e-b023-a23d280d496c2024-10-25WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyb6d9f421-b236-4660-be7f-85a878f2fc612024-10-25WarningsExact identifier
application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEFACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLCf9c3c12b-4efa-4ec4-a156-c403aff817532024-10-24WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLC1deb60f3-e9be-4756-b0c1-527ef00dc7412024-10-24WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
application number: M012
Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC68a5930b-37db-439d-8fb9-7d7de07d84652024-10-24WarningsExact identifier
application number: M012
sinus pressure pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INCbb0225d5-6c32-2c64-e053-2995a90a829b2024-10-24WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC01e1ad15-0ef5-4d6a-a9c1-19a5f2b201482024-10-24WarningsExact identifier
application number: M012
CareOne Fast Acting NasalPHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company95b22dce-ef54-4ab5-9cc3-0e1cefa09ec52024-10-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683422{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } PackGPCK179259a9-231e-df03-e063-6294a90a145e1
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) PackPSN179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD179259a9-231e-df03-e063-6294a90a145e1
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) PackSY179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydramine hydrochloride 50 MG per 40 ML Oral SolutionSY179259a9-231e-df03-e063-6294a90a145e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69536-315-04695360315041 in 1 CARTONHistorical
69536-345-04695360345041 in 1 CARTONHistorical
69536-355-08695360355081 KIT in 1 CARTON (69536-355-08) * 1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69536-315-04) / 118 mL in 1 BOTTLE1 kit2024-06-01NoNoCurrent