Unisom PM Pain Nighttime Sleep Aid and Pain Reliever

Product NDC
41167-0040
11-digit product format
411670040
Labeler code
41167
Product ID
41167-0040_75e0be81-2c6a-461a-9da5-c2aa060e2dc8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
325; 50 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

Additional Listing Data#

Finished product
Yes
Brand name base
Unisom PM Pain Nighttime Sleep Aid and Pain Reliever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1093075, 1093077

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
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16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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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
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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
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0040-2Unisom PM Pain Nighttime Sleep Aid and Pain Reliever1 in 1 CARTONTABLET, FILM COATED19
41167-0040-2Unisom PM Pain Nighttime Sleep Aid and Pain Reliever15 in 1 BOTTLETABLET, FILM COATED159
41167-0040-3Unisom PM Pain Nighttime Sleep Aid and Pain Reliever1 in 1 CARTONTABLET, FILM COATED19
41167-0040-3Unisom PM Pain Nighttime Sleep Aid and Pain Reliever20 in 1 BOTTLETABLET, FILM COATED209
41167-0040-4Unisom PM Pain Nighttime Sleep Aid and Pain Reliever30 in 1 BOTTLETABLET, FILM COATED309
41167-0040-4Unisom PM Pain Nighttime Sleep Aid and Pain Reliever1 in 1 CARTONTABLET, FILM COATED19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0040UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]8Current NDC, Legacy NDC, 6 package rows20231007_451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093075acetaminophen 325 MG / diphenhydrAMINE HCl 50 MG Oral TabletPSN451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093077Unisom PM Pain SleepCaps 325 MG / 50 MG Oral TabletPSN451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093077acetaminophen 325 MG / diphenhydramine hydrochloride 50 MG Oral Tablet [Unisom with Pain Relief]SBD451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093075acetaminophen 325 MG / diphenhydramine hydrochloride 50 MG Oral TabletSCD451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093075APAP 325 MG / diphenhydramine hydrochloride 50 MG Oral TabletSY451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093077APAP 325 MG / Diphenhydramine Hydrochloride 50 MG Oral Tablet [Unisom with Pain Relief]SY451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9
1093077Unisom with Pain Relief (APAP 325 MG / diphenhydramine hydrochloride 50 MG) Oral TabletSY451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0040-2411670040021 BOTTLE in 1 CARTON (41167-0040-2) / 15 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-12-010000-00-00NoNoCurrent
41167-0040-3411670040031 in 1 CARTONHistorical
41167-0040-4411670040041 BOTTLE in 1 CARTON (41167-0040-4) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-12-010000-00-00NoNoCurrent