Tylenol PM

Product NDC
67751-241
11-digit product format
677510241
Labeler code
67751
Product ID
67751-241_435b2b2a-6d47-1611-e063-6394a90a9f99
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-11
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
Tylenol 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, 1092378

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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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
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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
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b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-241-01Tylenol PMExtra Strength1 in 1 CARTONTABLET, FILM COATED11
67751-241-01Tylenol PMExtra Strength2 in 1 POUCHTABLET, FILM COATED21
67751-241-02Tylenol PMExtra Strength2 in 1 POUCHTABLET, FILM COATED21
67751-241-02Tylenol PMExtra Strength2 in 1 CARTONTABLET, FILM COATED21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN435b1a31-353d-af20-e063-6294a90aa9071
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN435b1a31-353d-af20-e063-6294a90aa9071
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD435b1a31-353d-af20-e063-6294a90aa9071
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD435b1a31-353d-af20-e063-6294a90aa9071
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY435b1a31-353d-af20-e063-6294a90aa9071
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY435b1a31-353d-af20-e063-6294a90aa9071
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY435b1a31-353d-af20-e063-6294a90aa9071
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY435b1a31-353d-af20-e063-6294a90aa9071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67751-241-01677510241011 POUCH in 1 CARTON (67751-241-01) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2025-03-11NoNoCurrent
67751-241-02677510241022 POUCH in 1 CARTON (67751-241-02) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2025-09-23NoNoCurrent