FDA.reportPublic FDA data

Panadol

Product NDC
0135-0607
11-digit product format
001350607
Labeler code
0135
Product ID
0135-0607_10c08cd4-8a3b-c9ad-e063-6394a90a9641
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and phenyleprine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-01
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Panadol
Brand name suffix
Cold and Flu NonDrowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f626ab17-01c9-4493-ba9e-0c8c11146384Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0607-022020-07-22C16284748780-1ab0e2407-34ee-f274-e053-dbdaa90a6471Drug Facts
0135-0607-032020-07-22C16284748780-1ab0e2407-34ee-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0607-01PanadolCold and Flu NonDrowsy2 in 1 PACKETTABLET, FILM COATED26
0135-0607-02PanadolCold and Flu NonDrowsy3 in 1 CARTONTABLET, FILM COATED36
0135-0607-02PanadolCold and Flu NonDrowsy8 in 1 BLISTER PACKTABLET, FILM COATED86
0135-0607-03PanadolCold and Flu NonDrowsy50 in 1 CARTONTABLET, FILM COATED506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0607-02EA - Each0135-06073d20babd-8f09-4f9a-a49a-c498993637c612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0607PANADOL COLD AND FLU NONDROWSY (ACETAMINOPHEN AND PHENYLEPRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240207_f626ab17-01c9-4493-ba9e-0c8c11146384.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 23 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHYVEE INC3e602287-565e-a5b9-e063-6294a90abc172026-01-13WarningsExact identifier
application number: M013
ASPIRIN DELAYED RELEASE 81MGASPIRIN DELAYED RELEASE 81MGFarmacias De Similares TX LLC3a8a3efc-f0b3-411c-e063-6394a90a84b72026-01-13WarningsExact identifier
application number: M013
Chewable Aspirin 81 mgASPIRINHYVEE INC459f749f-9d23-8752-e063-6394a90a8c812026-01-13WarningsExact identifier
application number: M013
ASPIRIN 325 mgASPIRINHYVEE INC459d01df-6ff6-cff6-e063-6394a90ab35c2026-01-13WarningsExact identifier
application number: M013
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
application number: M013
Aspirin PacksASPIRINSina Health Inc2865a2c3-53fc-ab9a-e063-6394a90a14182026-01-12WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
application number: M013
Aspirin enteric coated low doseASPIRINWalgreen Company186a6270-e3de-4499-88a4-5f723fee3e342026-01-12WarningsExact identifier
application number: M013
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINFamily Dollar Services Incd35d798e-76f1-454d-86f6-ad11c3bf17d82026-01-12WarningsExact identifier
application number: M013
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
application number: M013
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNf626ab17-01c9-4493-ba9e-0c8c111463846
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf626ab17-01c9-4493-ba9e-0c8c111463846
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf626ab17-01c9-4493-ba9e-0c8c111463846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0607-01001350607012 in 1 PACKETHistorical
0135-0607-02001350607023 BLISTER PACK in 1 CARTON (0135-0607-02) / 8 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2017-06-010000-00-00NoNoCurrent
0135-0607-030013506070350 PACKET in 1 CARTON (0135-0607-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01) 50 packet2017-06-010000-00-00NoNoCurrent