FDA.reportPublic FDA data

MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF

Product NDC
69842-442
11-digit product format
698420442
Labeler code
69842
Product ID
69842-442_4de8f8ce-ac96-9aa5-e063-6294a90adb85
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl And Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCl
Dosage form
KIT
Labeler
CVS Pharmacy, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-10
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-442-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-442-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-442-240efc9e666f02…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
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1297288Internal RxNorm lookup
1656815Internal RxNorm lookup
2634364Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c17d5ba7-3302-7931-e053-2a95a90a5a6cAvailable 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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-442-242025-02-13C16284748780-12cef2736-832b-d83d-e063-dadaa90ab31f630T CVS 69842-442 MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF
69842-442-242025-01-30C16284748780-12cef2736-832b-d83d-e063-dadaa90ab31f630T CVS 69842-442 MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-290-08MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86.25 mg4
69842-442-24MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF1 in 1 CARTONKIT14
69842-442-24MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF1 in 1 BLISTER PACKKIT14
69842-617-16MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED165 mg4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-442MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL) KIT [CVS PHARMACY, INC.]3Current NDC, Legacy NDC, 4 package rows20250215_c17d5ba7-3302-7931-e053-2a95a90a5a6c.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 94 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.33e259d6-b065-a677-e063-6394a90ab3142025-10-23WarningsExact identifier
application number: M012
Severe Nighttime Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy1ec3fc79-4f38-439f-99be-646b82231aa52025-10-23WarningsExact identifier
application number: M012
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine MaleateACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATECVS Pharmacy, Inc1532ee21-e114-ded7-e063-6294a90ab0252025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEMethod Pharmaceuticals, LLC5a60c923-8bb7-427f-9636-08ed5474f71b2025-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICE97ed70a0-b692-4c12-90d6-72b3c87e554c2025-10-21WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI13910ea1-37dd-43bb-9fe8-e843f59201b72025-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAmerisource Bergend6f185b6-8538-4eac-98da-83760c34b4882025-10-20WarningsExact identifier
application number: M012
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED92c570ff-139f-49ff-a7bd-8a540ecc07c72025-10-17WarningsExact identifier
application number: M012
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKc17d5ba7-3302-7931-e053-2a95a90a5a6c4
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDc17d5ba7-3302-7931-e053-2a95a90a5a6c4
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYc17d5ba7-3302-7931-e053-2a95a90a5a6c4
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYc17d5ba7-3302-7931-e053-2a95a90a5a6c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-290-08698420290088 in 1 BLISTER PACKHistorical
69842-442-24698420442241 BLISTER PACK in 1 CARTON (69842-442-24) / 1 KIT in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-617-16) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-290-08) 1 blister pack2021-07-100000-00-00NoNoCurrent
69842-617-166984206171616 in 1 BLISTER PACKHistorical