FDA.reportPublic FDA data

equate pain and fever

Product NDC
49035-042
11-digit product format
490350042
Labeler code
49035
Product ID
49035-042_1fb04a40-37cb-4802-84a6-487afbbab98e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-06
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
equate pain and fever
Brand name suffix
childrens
Listing expiration
2026-12-31

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
ea68d735-c677-4280-a3a3-ae3eb5ff7462Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-042-26equate pain and feverchildrens118 mL in 1 BOTTLESUSPENSION1186
49035-042-26equate pain and feverchildrens1 in 1 CARTONSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-042-26ML - Milliliter49035-042792859b4-22ec-458a-b194-0ccb1860642f12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-042EQUATE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 2 package rows20240822_ea68d735-c677-4280-a3a3-ae3eb5ff7462.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNea68d735-c677-4280-a3a3-ae3eb5ff74626
307668acetaminophen 32 MG/ML Oral SuspensionSCDea68d735-c677-4280-a3a3-ae3eb5ff74626
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYea68d735-c677-4280-a3a3-ae3eb5ff74626
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYea68d735-c677-4280-a3a3-ae3eb5ff74626
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYea68d735-c677-4280-a3a3-ae3eb5ff74626
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYea68d735-c677-4280-a3a3-ae3eb5ff74626
307668APAP 32 MG/ML Oral SuspensionSYea68d735-c677-4280-a3a3-ae3eb5ff74626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-042-26490350042261 BOTTLE in 1 CARTON (49035-042-26) / 118 mL in 1 BOTTLE1 bottle2015-11-060000-00-00NoNoCurrent