Home NDC 69729-047-02 Temp X
Product NDC 69729-047
Requested package NDC 69729-047-02
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 47 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Asclemed USA, Inc. 878dab20-668b-4d7a-a5f8-794a587564d5 2025-02-13 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN CVS HEALTH CORP bbc48c9e-7eb8-2c67-e053-2a95a90a8552 2025-02-13 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN CVS 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 2025-02-13 Warnings Exact identifier application number: M013 NOTTS - Extra Strength 500 mg ACETAMINOPHEN VIVUNT PHARMA LLC e677f43d-b4ce-e5b0-e053-2a95a90ad67e 2025-02-12 Warnings Exact identifier application number: M013 Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN, ASPIRIN, CAFFEINE LEADER/ Cardinal Health 110, Inc. b3773f02-02a9-33c8-e053-2995a90a2235 2025-02-11 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC. c9f80d24-bd05-e1ce-e053-2995a90aa646 2025-02-10 Warnings Exact identifier application number: M013
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