Home NDC 69729-047 Temp X
Product NDC 69729-047
11-digit product format 697290047
Labeler code 69729
Product ID 69729-047_26f62929-9f8c-7354-e063-6294a90a45b9
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 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 Temp X
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-047-02 Temp X 60 mL in 1 BOTTLE SUSPENSION 60 6 69729-047-04 Temp X 118 mL in 1 BOTTLE SUSPENSION 118 5 69729-047-04 Temp X 1 in 1 CARTON SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-047 ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.zip 69729-047 TEMP X (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA] 5 Current NDC, Legacy NDC, 2 package rows 20241116_fd2edc32-0351-c991-e053-6294a90ab4ce.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 39 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69729-047-02 69729004702 60 mL in 1 BOTTLE (69729-047-02) 60 ml 2021-02-01 0000-00-00 No No Current 69729-047-04 69729004704 1 BOTTLE in 1 CARTON (69729-047-04) / 118 mL in 1 BOTTLE 1 bottle 2023-06-02 No No Current