FDA.reportPublic FDA data

Pain Relief PM

Product NDC
36800-556
11-digit product format
368000556
Labeler code
36800
Product ID
36800-556_ded0a100-68b0-425e-8e0a-5fd6b7c4239f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Topco Associates, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-03
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Pain Relief PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 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
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaa98783-5800-4ae9-832f-f4a1fd1790fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-556-09Pain Relief PM20 in 1 BOTTLE, PLASTICTABLET, COATED2011
36800-556-09Pain Relief PM1 in 1 CARTONTABLET, COATED111
36800-556-10Pain Relief PM1 in 1 CARTONTABLET, COATED111
36800-556-10Pain Relief PM40 in 1 BOTTLE, PLASTICTABLET, COATED4011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-556PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [TOPCO ASSOCIATES, LLC]10Current NDC, Legacy NDC, 4 package rows20250316_eaa98783-5800-4ae9-832f-f4a1fd1790fd.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 74 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact identifier
application number: M013
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNeaa98783-5800-4ae9-832f-f4a1fd1790fd11
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDeaa98783-5800-4ae9-832f-f4a1fd1790fd11
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYeaa98783-5800-4ae9-832f-f4a1fd1790fd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-556-09368000556091 BOTTLE, PLASTIC in 1 CARTON (36800-556-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2020-01-030000-00-00NoNoCurrent
36800-556-10368000556101 BOTTLE, PLASTIC in 1 CARTON (36800-556-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2020-01-030000-00-00NoNoCurrent