FDA.reportPublic FDA data

FLO PMS Complete

Product NDC
83049-489
11-digit product format
830490489
Labeler code
83049
Product ID
83049-489_a0526808-00a6-42a5-aeb8-42db54626a28
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine, Pyrilamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
O Positiv, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-05
Substance
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength
500; 60; 15 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
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
FLO PMS Complete
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cce62d9f-adb1-4473-8258-910dff6b1378Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83049-489-08FLO PMS Complete8 in 1 BLISTER PACKTABLET84
83049-489-08FLO PMS Complete3 in 1 CARTONTABLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83049-489FLO PMS COMPLETE (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET [O POSITIV, INC.]4Current NDC, Legacy NDC, 2 package rows20231010_cce62d9f-adb1-4473-8258-910dff6b1378.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNcce62d9f-adb1-4473-8258-910dff6b13784
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDcce62d9f-adb1-4473-8258-910dff6b13784
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYcce62d9f-adb1-4473-8258-910dff6b13784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83049-489-08830490489083 BLISTER PACK in 1 CARTON (83049-489-08) / 8 TABLET in 1 BLISTER PACK3 blister pack2022-12-050000-00-00NoNoCurrent