Genexa Infants Pain and Fever

Product NDC
69676-0042
11-digit product format
696760042
Labeler code
69676
Product ID
69676-0042_51588b9a-d5ac-4667-e063-6294a90a432c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Genexa Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-10
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
Genexa Infants Pain and Fever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c59cbf0e-1381-4dd2-e053-2a95a90a853aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0042-9Genexa Infants Pain and Fever1 in 1 CARTONSUSPENSION18
69676-0042-9Genexa Infants Pain and Fever59 mL in 1 BOTTLESUSPENSION598

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0042GENEXA INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [GENEXA INC.]6Current NDC, Legacy NDC, 2 package rows20250406_c59cbf0e-1381-4dd2-e053-2a95a90a853a.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 65 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.5411544e-3c2d-4e42-e054-00144ff8d46c2024-07-10WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL. Perrigo Companyb97c51ad-4953-4491-9ceb-395550eb52962024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens065e6f1b-f68c-491a-a157-84961a07e3d92024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens3b7b6725-2996-44d3-89a3-032384e7e2ce2024-07-10WarningsExact identifier
application number: M013
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWinCo Foods, LLC3c57498c-86b0-4ba3-881e-c742a2e8ece52024-07-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWinCo Foods, LLCc358d1dd-9fcb-4d18-9521-8f898b98a7322024-07-09WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENWinCo Foods, LLC15430025-f25e-4fe7-b1fe-4eda4684081a2024-07-09WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENWinCo Foods, LLC0631f003-4852-4034-a1c5-1552804b16602024-07-09WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBryant Ranch Prepack61ecf3c9-42fa-4ae4-bd3b-694090477b9a2024-07-09WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCfa0ce51f-441d-4409-8617-b3402b00f1872024-07-08WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENMeijer Distribution Inc81d4e8f5-2f15-462b-be71-ef05f0b791ab2024-07-05WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack31a97a6a-e5c8-429a-b497-330f0d84777d2024-07-05WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inc375b2142-3c89-469c-98fd-bd4b63aeaa112024-07-05WarningsExact identifier
application number: M013
Best Choice Effervescent Pain Reliever 36ASPIRINVALU MERCHANDISERS COMPANY12f1278e-88b6-0460-e063-6394a90abf0e2024-07-03WarningsExact identifier
application number: M013
Topcare pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWALMART INC.16d5b56f-7e56-0c91-e063-6394a90a4b8e2024-07-03WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.16d5786c-2346-f970-e063-6394a90a0a8c2024-07-03WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668acetaminophen 32 MG/ML Oral SuspensionSCDc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYc59cbf0e-1381-4dd2-e053-2a95a90a853a8
307668APAP 32 MG/ML Oral SuspensionSYc59cbf0e-1381-4dd2-e053-2a95a90a853a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0042-9696760042091 BOTTLE in 1 CARTON (69676-0042-9) / 59 mL in 1 BOTTLE1 bottle2025-03-100000-00-00NoNoCurrent