FDA.reportPublic FDA data

MAX relief junior

Product NDC
71399-0038
11-digit product format
713990038
Labeler code
71399
Product ID
71399-0038_4227b3f5-e0ae-9804-e063-6294a90a11b7
Type
HUMAN OTC DRUG
Nonproprietary name
Children Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-18
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAX relief junior
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0038-4MAX relief junior1 in 1 CARTONSUSPENSION13
71399-0038-4MAX relief junior118 mL in 1 BOTTLESUSPENSION1183
71399-0038-6MAX relief junior473 mL in 1 BOTTLESUSPENSION4733
71399-0038-8MAX relief junior1 in 1 CARTONSUSPENSION13
71399-0038-8MAX relief junior236 mL in 1 BOTTLESUSPENSION2363

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0038-4ML - Milliliter71399-003829afcbf4-0997-429a-90a7-04941d424fc412024-06-10
71399-0038-6ML - Milliliter71399-0038ec196839-af1a-41e5-ba7b-ae1210b070d812024-06-10
71399-0038-8ML - Milliliter71399-0038e7c8d9e8-9616-4443-bbde-97ce6850795112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0038MAX RELIEF JUNIOR (CHILDREN ACETAMINOPHEN) SUSPENSION [AKRON PHARMA INC.]2Current NDC, 5 package rows20240430_d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668acetaminophen 32 MG/ML Oral SuspensionSCDd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93
307668APAP 32 MG/ML Oral SuspensionSYd7874e4d-0b38-4bb1-9a62-aa4f66d9baf93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0038-4713990038041 BOTTLE in 1 CARTON (71399-0038-4) / 118 mL in 1 BOTTLE1 bottle2024-03-18NoNoHistorical
71399-0038-671399003806473 mL in 1 BOTTLE (71399-0038-6) 473 ml2024-04-24NoNoHistorical
71399-0038-8713990038081 BOTTLE in 1 CARTON (71399-0038-8) / 236 mL in 1 BOTTLE1 bottle2024-04-24NoNoHistorical