FDA.reportPublic FDA data

NDC 70875-500-01 - SP Pharma

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70875-500
Requested NDC
70875-500-01
Package NDCs from labels
70875-500-01, 70875-500-02, 70875-500-03, 70875-500-04, 70875-500-05
Manufacturer
Simpor Pharma Sdn Bhd
Effective date
2019-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SP Pharma - Simpor Pharma Sdn BhdSimpor Pharma Sdn Bhd2019-01-30HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70875-500-022023-01-30C16284748780-1f386c64a-1be5-0266-e053-dadaa90a7c1abd85912e-23bf-499f-b91d-7ff17f61c8df
70875-500-042023-01-30C16284748780-1f386c64a-1be5-0266-e053-dadaa90a7c1abd85912e-23bf-499f-b91d-7ff17f61c8df
70875-500-052023-01-30C16284748780-1f386c64a-1be5-0266-e053-dadaa90a7c1abd85912e-23bf-499f-b91d-7ff17f61c8df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70875-500-01SP Pharma500 mg in 1 PACKAGETABLET5002
70875-500-02SP Pharma200 in 1 BOTTLETABLET2002
70875-500-03SP Pharma1500 mg in 1 DOSE PACKTABLET15002
70875-500-04SP Pharma20 in 1 CARTONTABLET202
70875-500-05SP Pharma30 in 1 CARTONTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70875-500SP PHARMA (ACETAMINOPHEN) TABLET [SIMPOR PHARMA SDN BHD]2Legacy NDC, 5 package rows20190130_bd85912e-23bf-499f-b91d-7ff17f61c8df.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 2 of 155 · 3,090 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsExact identifier
unii: 362O9ITL9D
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.