FDA.reportPublic FDA data

Pain Relief Acetaminophen PM

Product NDC
11822-2350
11-digit product format
118222350
Labeler code
11822
Product ID
11822-2350_267b7159-6f61-49de-9cb8-1ec7e4314933
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1994-05-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief Acetaminophen PM
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
11822-2350-2Pain Relief Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, FILM COATED127
11822-2350-2Pain Relief Acetaminophen PMExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10027
11822-2350-4Pain Relief Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, FILM COATED127
11822-2350-4Pain Relief Acetaminophen PMExtra Strength2 in 1 BLISTER PACKTABLET, FILM COATED227
11822-2350-5Pain Relief Acetaminophen PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5027
11822-2350-5Pain Relief Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, FILM COATED127
11822-2350-7Pain Relief Acetaminophen PMExtra Strength300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30027
11822-2350-8Pain Relief Acetaminophen PMExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2427
11822-2350-8Pain Relief Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, FILM COATED127
11822-2350-9Pain Relief Acetaminophen PMExtra Strength150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15027
11822-2350-9Pain Relief Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, FILM COATED127

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-2350PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]26Current NDC, Legacy NDC, 11 package rows20240718_17d27771-a112-474f-9a58-29af0d7e1af3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN17d27771-a112-474f-9a58-29af0d7e1af327
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD17d27771-a112-474f-9a58-29af0d7e1af327
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY17d27771-a112-474f-9a58-29af0d7e1af327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-2350-2118222350021 BOTTLE, PLASTIC in 1 CARTON (11822-2350-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1994-05-150000-00-00NoNoCurrent
11822-2350-4118222350041 BLISTER PACK in 1 CARTON (11822-2350-4) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1994-05-150000-00-00NoNoCurrent
11822-2350-5118222350051 BOTTLE, PLASTIC in 1 CARTON (11822-2350-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1994-05-150000-00-00NoNoCurrent
11822-2350-711822235007300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-2350-7) 1994-05-150000-00-00NoNoCurrent
11822-2350-8118222350081 BOTTLE, PLASTIC in 1 CARTON (11822-2350-8) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-04-03NoNoHistorical
11822-2350-9118222350091 BOTTLE, PLASTIC in 1 CARTON (11822-2350-9) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-03-16NoNoHistorical