FDA.reportPublic FDA data

Mejoralito

Product NDC
69729-068
11-digit product format
697290068
Labeler code
69729
Product ID
69729-068_26f5f344-a410-591c-e063-6294a90a39a0
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
Mejoralito
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd2ecde0-296e-060f-e053-6294a90afd98Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-068-04Mejoralito1 in 1 CARTONSUSPENSION18
69729-068-04Mejoralito118 mL in 1 BOTTLESUSPENSION1188
69729-068-02Mejoralito60 mL in 1 BOTTLESUSPENSION606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-068MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]8Current NDC, Legacy NDC, 2 package rows20241116_fd2ecde0-296e-060f-e053-6294a90afd98.zip
69729-068ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC]5Current NDC, Legacy NDC, 1 package rows20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.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 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
application number: M013
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALGREENS40b4fe91-b1dd-147c-e063-6294a90a807d2026-06-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
application number: M013
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
application number: M013
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINRugby Laboratories63fcd93a-b1db-44ba-8f2b-055a7deb205d2026-06-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
application number: M013
Aspirin Adult low doseACETYLSALICYCLIC ACIDMedline Industries, LP6dd6501f-841c-4994-e053-2a91aa0ae2312026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECVS Pharmacy749e2be2-594a-4052-8fa5-45c9ade2d23c2026-06-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 32 MG/ML Oral SuspensionSCDfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfd2ecde0-296e-060f-e053-6294a90afd988
307668APAP 32 MG/ML Oral SuspensionSYfd2ecde0-296e-060f-e053-6294a90afd988
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 32 MG/ML Oral SuspensionSCD5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668APAP 32 MG/ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-068-026972900680260 mL in 1 BOTTLE (69729-068-02) 60 ml2021-02-010000-00-00NoNoCurrent
69729-068-04697290068041 BOTTLE in 1 CARTON (69729-068-04) / 118 mL in 1 BOTTLE1 bottle2023-06-02NoNoCurrent