FDA.reportPublic FDA data

Neo-Lubrina

Product NDC
69729-118
11-digit product format
697290118
Labeler code
69729
Product ID
69729-118_5c3f9d3e-5df2-1696-e063-6394a90a5154
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
Neo-Lubrina
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
69729-118-04Neo-Lubrina118 mL in 1 BOTTLESUSPENSION1184
69729-118-04Neo-Lubrina1 in 1 CARTONSUSPENSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-118NEO-LUBRINA (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]4Current NDC, 2 package rows20241116_fd3ca168-23b9-3eb8-e053-6394a90ac89b.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 50 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INC8f221fdb-8138-c1a8-e053-2995a90a29c22025-01-11WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions3294ba24-f198-485e-88fc-435964434b802025-01-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLCe817bc4a-43ef-4126-b903-aabd1390cd0c2025-01-08WarningsExact identifier
application number: M013
GeriCare Liquid Pain ReliefACETAMINOPHENGeri-Care Pharmaceuticals, Corp85a074da-14b7-4db5-9d47-8ad19f5207212025-01-06WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINMeijer Distribution Inceb29d6be-f095-44b2-b6ed-7e4167b596f82025-01-02WarningsExact identifier
application number: M013
Headache, Circle KACETAMINOPHEN, CAFFEINE, ASPIRIN TABLETLil' Drug Store Products, Inc.e711ff0a-2fa0-1f2a-e053-2a95a90a4e382024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Lil Drug StoreEXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0c41deda-490b-f5d2-e063-6394a90a50472024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED TABLETLil' Drug Store Products, Inc.e5f9def4-4cf5-4e06-e053-2995a90a07ea2024-12-31WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
application number: M013
AspirinASPIRINAdvanced Rx Pharmacy of Tennessee, LLCf8375029-e567-c6a5-e053-6394a90a5b672024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEDollar General4907056d-6013-46b1-ae86-469dc30015912024-12-31WarningsExact identifier
application number: M013
Pediacare Childrens GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHf9d531a2-234c-4feb-8f05-212dbee83dfe2024-12-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668acetaminophen 32 MG/ML Oral SuspensionSCDfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfd3ca168-23b9-3eb8-e053-6394a90ac89b4
307668APAP 32 MG/ML Oral SuspensionSYfd3ca168-23b9-3eb8-e053-6394a90ac89b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-118-04697290118041 BOTTLE in 1 CARTON (69729-118-04) / 118 mL in 1 BOTTLE1 bottle2023-06-02NoNoCurrent