FDA.reportPublic FDA data

MAX relief junior

Product NDC
71399-0020
11-digit product format
713990020
Labeler code
71399
Product ID
71399-0020_483855d3-1d42-b363-e063-6294a90ae9a0
Type
HUMAN OTC DRUG
Nonproprietary name
Childrens Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAX relief junior
Listing expiration
2027-12-31

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
71399-0020-4MAX relief junior1 in 1 CARTONLIQUID12
71399-0020-4MAX relief junior118 mL in 1 BOTTLELIQUID1182
71399-0020-6MAX relief junior473 mL in 1 BOTTLELIQUID4732
71399-0020-8MAX relief junior1 in 1 CARTONLIQUID12
71399-0020-8MAX relief junior236 mL in 1 BOTTLELIQUID2362

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0020-4ML - Milliliter71399-00207a364196-0d06-45ed-8e6c-33e8737fdf5612024-08-12
71399-0020-6ML - Milliliter71399-0020d56d3611-fed1-480c-a215-644c68db360812024-08-12
71399-0020-8ML - Milliliter71399-0020a1370efd-121f-4f77-8b54-f607d706fe8b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0020MAX RELIEF JUNIOR (CHILDRENS ACETAMINOPHEN) LIQUID [AKRON PHARMA INC.]1Current NDC, 5 package rows20240713_ebb3b4ba-2d0b-48d9-b6ee-6d4696aea047.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668acetaminophen 32 MG/ML Oral SuspensionSCDebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472
307668APAP 32 MG/ML Oral SuspensionSYebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0020-4713990020041 BOTTLE in 1 CARTON (71399-0020-4) / 118 mL in 1 BOTTLE1 bottle2024-07-01NoNoHistorical
71399-0020-671399002006473 mL in 1 BOTTLE (71399-0020-6) 473 ml2024-07-01NoNoHistorical
71399-0020-8713990020081 BOTTLE in 1 CARTON (71399-0020-8) / 236 mL in 1 BOTTLE1 bottle2024-07-01NoNoHistorical