FDA.reportPublic FDA data

Pain Relief PM

Product NDC
63868-119
11-digit product format
638680119
Labeler code
63868
Product ID
63868-119_68f2d380-71de-422f-808a-77316fcf3017
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-31
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
Brand name suffix
Extra Strength
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
47660794-22cc-4863-a183-e694d27e3543Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-119-50Pain Relief PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED507
63868-119-50Pain Relief PMExtra Strength1 in 1 BOXTABLET, COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-119-50EA - Each63868-119ff37b51e-5667-4fa3-bdd8-9552e2dc64da12022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-119PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]7Current NDC, Legacy NDC, 2 package rows20240420_47660794-22cc-4863-a183-e694d27e3543.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 70 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Honey Lemon Cough DropsHONEY LEMON COUGH DROPSChain Drug Marketing Association, Inc.1fd09b04-9c79-da20-e063-6394a90ae2632025-12-22WarningsExact identifier
application number: M012
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012
CAREALL DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incf3b177ef-55d5-4525-bf33-99205c414a5b2025-12-22WarningsExact identifier
application number: M012
CAREALL Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incaf2f8389-d696-4060-8abd-6eda04e730092025-12-22WarningsExact identifier
application number: M012
BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC82e68c65-9898-4106-a2f8-e39d124c703e2025-12-22WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLWalgreens464f6645-ca33-1722-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalgreen Co.47f38e79-c730-21b9-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLWalgreen Co.47522852-005a-2a66-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreens Co,47653657-80b5-482f-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreen Co.47f89d33-6e0a-4bb4-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Strawberry Cough DropMENTHOL 2.7 MGWalgreen Co.4766afa8-fdaf-05e5-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLWalgreen Co.477b9fc3-c3c5-647e-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropMENTHOLWalgreen Co.477cedee-6bd3-2a34-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEWalgreens Co.47e0f809-0b30-2b23-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalgreen835e276a-493e-1038-e053-2a91aa0a7ea22025-12-21WarningsExact identifier
application number: M012
Walgreens Mixed Berry Benz-Dex LozengesBENZOCAINEWalgreene108731f-6b77-225a-e053-2a95a90ac25c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalmart Stores Inc.318e7acb-0ebb-4518-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWalmart Stores Inc.316968e1-7715-4caa-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN47660794-22cc-4863-a183-e694d27e35437
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD47660794-22cc-4863-a183-e694d27e35437
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY47660794-22cc-4863-a183-e694d27e35437

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-119-50638680119501 BOTTLE, PLASTIC in 1 BOX (63868-119-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2015-05-310000-00-00NoNoCurrent