FDA.reportPublic FDA data

Temperal-ito

Product NDC
69729-006
11-digit product format
697290006
Labeler code
69729
Product ID
69729-006_26f5f344-a40f-591c-e063-6294a90a39a0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
OPMX Chula Vista
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-02
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
Temperal-ito
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
69729-006-02Temperal-ito60 mL in 1 BOTTLESUSPENSION606
69729-006-02Temperal-ito1 in 1 CARTONSUSPENSION16
69729-006-04Temperal-ito1 in 1 CARTONSUSPENSION16
69729-006-04Temperal-ito118 mL in 1 BOTTLESUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-006TEMPERAL-ITO (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]6Current NDC, 4 package rows20241116_fd2d85a0-4bc6-3ed0-e053-6294a90a8494.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668acetaminophen 32 MG/ML Oral SuspensionSCDfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfd2d85a0-4bc6-3ed0-e053-6294a90a84946
307668APAP 32 MG/ML Oral SuspensionSYfd2d85a0-4bc6-3ed0-e053-6294a90a84946

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-006-02697290006021 BOTTLE in 1 CARTON (69729-006-02) / 60 mL in 1 BOTTLE1 bottle2023-06-02NoNoHistorical
69729-006-04697290006041 BOTTLE in 1 CARTON (69729-006-04) / 118 mL in 1 BOTTLE1 bottle2023-06-02NoNoHistorical