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 46 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES LOW DOSE Aspirin 81mgASPIRINStrive Pharmaceuticals Inc.322c0e50-cf75-51ab-e063-6294a90a92352025-04-14WarningsExact identifier
application number: M013
Bayer Aspirin Regimen Chewable Low Dose Aspirin OrangeASPIRINBayer HealthCare LLC.0c6ae05f-760f-34d1-e054-00144ff88e882025-04-11WarningsExact identifier
application number: M013
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
application number: M013
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINNuCare Pharmaceuticals, Inc.324937c3-c558-bc79-e063-6294a90acc8e2025-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINBryant Ranch Prepack9d0449d2-c0c6-4e74-931b-35dc625840282025-03-31WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINBryant Ranch Prepackcce1e8bd-63c8-403a-bc32-e6788493f6042025-03-31WarningsExact identifier
application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
application number: M013
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
application number: M013
CounterAct PainACETAMINOPHENMelaleuca, Inc.7faf76b4-7f25-377d-e053-2a91aa0a19d42025-03-20Boxed warning, WarningsExact identifier
application number: M013
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
application number: M013
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
application number: M013
Signature Select Effervescent Pain ReliefASPIRINSafeway Inc.304fca65-2867-c963-e063-6394a90a183f2025-03-14WarningsExact 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