Home NDC 69729-006 Temperal-ito
Product NDC 69729-006
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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 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 Sample Exclude flag Status 69729-006-02 69729000602 1 BOTTLE in 1 CARTON (69729-006-02) / 60 mL in 1 BOTTLE 1 bottle 2023-06-02 No No Current 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