Sinus Relief

Product NDC
69842-882
11-digit product format
698420882
Labeler code
69842
Product ID
69842-882_523977ae-9c49-4699-8c95-24efba4a09b7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl
Dosage form
KIT
Labeler
CVS PHARMACY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-01
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
Sinus Relief
Brand name suffix
Daytime, Nighttime, Maximum Strength
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
1233575Internal RxNorm lookup
1243679Internal RxNorm lookup
2634398Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6b3ca40-7638-477f-b800-4c28c40ff0a8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-882-09Sinus ReliefDaytime, Nighttime, Maximum Strength1 in 1 CARTONKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-882SINUS RELIEF DAYTIME, NIGHTTIME, MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]12Current NDC, Legacy NDC, 1 package rows20241109_f6b3ca40-7638-477f-b800-4c28c40ff0a8.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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634398{1 (acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKf6b3ca40-7638-477f-b800-4c28c40ff0a814
1233575acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletPSNf6b3ca40-7638-477f-b800-4c28c40ff0a814
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf6b3ca40-7638-477f-b800-4c28c40ff0a814
2634398daytime 1 (acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / nighttime 1 (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSNf6b3ca40-7638-477f-b800-4c28c40ff0a814
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf6b3ca40-7638-477f-b800-4c28c40ff0a814
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf6b3ca40-7638-477f-b800-4c28c40ff0a814
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSYf6b3ca40-7638-477f-b800-4c28c40ff0a814
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf6b3ca40-7638-477f-b800-4c28c40ff0a814
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf6b3ca40-7638-477f-b800-4c28c40ff0a814
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf6b3ca40-7638-477f-b800-4c28c40ff0a814
2634398daytime 1 (acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / nighttime 1 (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet) PackSYf6b3ca40-7638-477f-b800-4c28c40ff0a814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-882-09698420882091 KIT in 1 CARTON (69842-882-09) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK1 kit2017-07-010000-00-00NoNoCurrent