FDA.reportPublic FDA data

Allergy Plus Congestion Relief

Product NDC
51316-485
11-digit product format
513160485
Labeler code
51316
Product ID
51316-485_f605920f-a072-4f47-bc0b-0c1c90a4469d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-09
Marketing end
2027-10-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
25; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
Allergy Plus Congestion Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal 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
1052928Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d2cf481-622f-4262-b0bd-c38fe5de6721Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-485-08Allergy Plus Congestion Relief2 in 1 CARTONTABLET, FILM COATED26
51316-485-08Allergy Plus Congestion Relief12 in 1 BLISTER PACKTABLET, FILM COATED126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-485ALLERGY PLUS CONGESTION RELIEF (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]4Current NDC, Legacy NDC, 2 package rows20240825_0d2cf481-622f-4262-b0bd-c38fe5de6721.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 61 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c1fae6c7-bbac-1320-e053-2a95a90aac5a2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
application number: M012
VanaCof 2CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATEGM Pharmaceuticals, INC0c7c6756-abb2-c10c-e063-6394a90a98632026-01-08WarningsExact identifier
application number: M012
VANACOF XP Cough / Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGM Pharmaceuticals, INC0b3a8cc1-a49f-e1e5-e063-6394a90a1c062026-01-08WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC868ac65a-63e2-46ac-b87d-66b2890867562026-01-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
application number: M012
Sambrosa NightDOXYLAMINE SUCCINATESambrosa Care, Inc.acdc8740-6231-d1e8-e053-2995a90a3b8d2026-01-07WarningsExact identifier
application number: M012
VAPOREXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDLC Laboratories, Inc.971943b1-4199-4f75-9d2d-61242d346b5f2026-01-07WarningsExact identifier
application number: M012
BACTIMICINA COUGH AND COLDDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDLC Laboratories, Inc.2e612c62-9bbb-45f2-a253-aa2bfaeaac702026-01-07WarningsExact identifier
application number: M012
Earths Care Chest RubCAMPHOR, EUCALYPTUS OI, MENTHOLDLC Laboratories, Inc2424f5d5-1772-96f1-e063-6294a90a89ee2026-01-07WarningsExact identifier
application number: M012
Bactimicina Vapor RubVAPOR RUBDLC Laboratories, Inc.176b617a-faf6-7893-e063-6294a90a046b2026-01-07WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company80b218f7-66bb-4e15-a0dc-ec9b6af1b0562026-01-07WarningsExact identifier
application number: M012
tussin cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation13618054-d0c5-4190-b626-e7e91b8557382026-01-06WarningsExact identifier
application number: M012
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052928diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral TabletPSN0d2cf481-622f-4262-b0bd-c38fe5de67216
1052928diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD0d2cf481-622f-4262-b0bd-c38fe5de67216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-485-08513160485082 BLISTER PACK in 1 CARTON (51316-485-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-08-092027-10-31NoNoCurrent