FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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

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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain Relief Dye freeACTEMINOPHENBETTER LIVING BRANDS LLC.41f504d1-29c4-f075-e063-6394a90ad64c2026-04-11WarningsExact identifier
application number: M013
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAkron Pharma Inc.e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed2026-04-10WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.28413cb3-22c4-40e2-ad6b-42beb438dea32026-04-10WarningsExact identifier
application number: M013
Pain Reliever ChildrensACETAMINOPHENH E B7e43de11-d20b-4920-a04d-3c1b5d35e0052026-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINNavajo Manufacturing Company Inc.f6f2ce71-5728-aefb-e053-6394a90a20e42026-04-08WarningsExact identifier
application number: M013
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
Pain Relief Aspirin Low DoseASPIRINRite Aid Corporation503408ed-e799-48a0-8d38-3034f4a0ead52026-04-02WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINLidl US LLC468f4a2f-60f7-4808-95d7-a00be1bb112f2026-04-02WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENGrocery Outlet, Inc.44de6f5a-0b5c-6c28-e063-6394a90a7e0b2026-04-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICE26ae0d0a-34c0-4d16-951a-8d5a463c808b2026-04-02WarningsExact identifier
application number: M013
Pain Reliever plus Sleep Aid NightTimeACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger Company286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d02026-04-02WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINCOSTCO WHOLESALE CORPORATIONc8a8986b-1ab4-9da0-71da-42595db08b442026-04-02WarningsExact identifier
application number: M013

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 bottle2023-06-02NoNoCurrent
69729-006-04697290006041 BOTTLE in 1 CARTON (69729-006-04) / 118 mL in 1 BOTTLE1 bottle2023-06-02NoNoCurrent