Home NDC 69729-006-04 Temperal-ito
Product NDC 69729-006
Requested package NDC 69729-006-04
11-digit product format 697290006
Labeler code 69729
Product ID 69729-006_5c3f89b8-a415-d1b8-e063-6394a90aa0e3
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 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 Temperal-ito
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-006-02 Temperal-ito 60 mL in 1 BOTTLE SUSPENSION 60 6 69729-006-02 Temperal-ito 1 in 1 CARTON SUSPENSION 1 6 69729-006-04 Temperal-ito 1 in 1 CARTON SUSPENSION 1 6 69729-006-04 Temperal-ito 118 mL in 1 BOTTLE SUSPENSION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-006 TEMPERAL-ITO (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA] 6 Current NDC, 4 package rows 20241116_fd2d85a0-4bc6-3ed0-e053-6294a90a8494.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 78 of 79 · 1,570 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69729-006-04 69729000604 1 BOTTLE in 1 CARTON (69729-006-04) / 118 mL in 1 BOTTLE 1 bottle 2023-06-02 No No Current