FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-004041167-0040-3DDiscontinued by firm2026-10-27

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1093075Internal RxNorm lookup
1093077Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
451daeeb-88a9-44b1-9a2d-1ff0b0ec41cbAvailable 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
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

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 75 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP402c8563-b14b-453f-80bc-4275f1c737022023-12-01WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLCbc03fa56-8880-4bbd-81a0-91853fecdd4e2023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCd59c5f04-4bcc-4a52-a42f-e049506f00de2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCa769094b-1e91-4ca7-ba67-21aa7e3129102023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013

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