FDA.reportPublic FDA data

Maximum Strength Non Drowsy Day and Night Cold and Flu

Product NDC
49035-674
11-digit product format
490350674
Labeler code
49035
Product ID
49035-674_4948f8ec-a55e-c624-e063-6394a90a49f8
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Non Drowsy Day and Night Cold and Flu
Dosage form
KIT
Labeler
WAL-MART STORES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-16
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
Maximum Strength Non Drowsy Day and Night Cold and Flu
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
1086997Internal RxNorm lookup
1297288Internal RxNorm lookup
2634363Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6a35fb8-1899-4da2-ad2b-0423e332845dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-674-162023-12-20C16284748780-1f386c649-fb74-0266-e053-dadaa90a7c1aEquate Maximum Strength Non Drowsy Day and Night Cold & Flu
49035-674-162023-01-30C16284748780-1f386c649-fb74-0266-e053-dadaa90a7c1aEquate Maximum Strength Non Drowsy Day and Night Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-674-16Maximum Strength Non Drowsy Day and Night Cold and Flu1 in 1 CARTONKIT16
79903-245-12Maximum Strength Non Drowsy Day and Night Cold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125 mg6
79903-246-04Maximum Strength Non Drowsy Day and Night Cold and Flu4 in 1 BLISTER PACKCAPSULE, LIQUID FILLED4 in 25 mg6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-674MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU KIT [WAL-MART STORES INC]5Current NDC, Legacy NDC, 3 package rows20250101_d6a35fb8-1899-4da2-ad2b-0423e332845d.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 158 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb8927b-22c5-2ca3-e063-6294a90aa5632024-08-02WarningsExact identifier
application number: M012
No Drip Severe Anefrin Nasal0.05% OXYMETAZOLINE HCLWalgreens Companyc126e969-56f3-47b4-a011-02ff150eccb82024-08-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation90e0426b-654f-4bcd-8b1d-cf56d1fc0c682024-07-27WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HCLA-S Medication Solutions0e81a937-59e5-4869-8ffb-c758fb37230d2024-07-23WarningsExact identifier
application number: M012
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
application number: M012
Night Time Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1f3eeb6c-4c44-4e2a-ad72-12c95e6589c92024-07-22WarningsExact identifier
application number: M012
CareOne Childrens Allergy ReliefDIPHENHYDRAMINE HCLAmerican Sales Companybb78ef2c-4f42-4e8f-b38d-f9b2965a384b2024-07-19WarningsExact identifier
application number: M012
dg health allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, LLC71445443-34bd-4d8c-b9c8-e7c3b8d4c8322024-07-19WarningsExact identifier
application number: M012
basic care childrens allergy reliefDIPHENHYDRAMINE HCLAmazon.com Services LLC75b9ee90-ad26-433e-8b90-97441b8d1e152024-07-19WarningsExact identifier
application number: M012
Cold and Flu Severe Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC9b74dd00-8f84-4fce-b5ea-df886b5953262024-07-18WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
application number: M012
equate allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb05acd16-21cb-4ee0-afa0-8f7d591664352024-07-18WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLPublix Super Markets Inccc6e4e26-84f5-4003-b1eb-f0e06d3e294e2024-07-18WarningsExact identifier
application number: M012
childrens allergyDIPHENHYDRAMINE HYDROCHLORIDEKroger Company10ebc7f8-dc8a-4640-8f87-d0d073998fd52024-07-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergenb173cc2c-7c4c-4f9e-a920-c71bc256ec1e2024-07-18WarningsExact identifier
application number: M012
ALLERGYCHLORPHENIRAMINE MALEATEA-S Medication Solutionsb199b5ee-fff3-4746-be68-a04060586f8e2024-07-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLH E B2d1715b3-b1cf-455d-9909-f6d58c97db402024-07-18WarningsExact identifier
application number: M012
careone allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmerican Sales Companyed4038fc-ab39-4567-9961-2b390b91b1262024-07-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{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 / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKd6a35fb8-1899-4da2-ad2b-0423e332845d6
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 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) PackPSNd6a35fb8-1899-4da2-ad2b-0423e332845d6
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNd6a35fb8-1899-4da2-ad2b-0423e332845d6
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNd6a35fb8-1899-4da2-ad2b-0423e332845d6
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDd6a35fb8-1899-4da2-ad2b-0423e332845d6
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDd6a35fb8-1899-4da2-ad2b-0423e332845d6
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 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) PackSYd6a35fb8-1899-4da2-ad2b-0423e332845d6
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYd6a35fb8-1899-4da2-ad2b-0423e332845d6
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYd6a35fb8-1899-4da2-ad2b-0423e332845d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-674-16490350674161 KIT in 1 CARTON (49035-674-16) * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (79903-245-12) * 1 BLISTER PACK in 1 CARTON / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (79903-246-04) 1 kit2020-11-160000-00-00NoNoCurrent
79903-245-127990302451212 in 1 BLISTER PACKHistorical
79903-246-04799030246044 in 1 BLISTER PACKHistorical