FDA.reportPublic FDA data

Acetaminophen

Product NDC
55301-175
11-digit product format
553010175
Labeler code
55301
Product ID
55301-175_6e7ae313-a4de-4d8d-a4e5-6add736012ef
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-04-02
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
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
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
55301-175-03Acetaminophen1 in 1 CARTONTABLET, FILM COATED126
55301-175-03Acetaminophen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1026
55301-175-06Acetaminophen2 in 1 CARTONTABLET, FILM COATED226
55301-175-06Acetaminophen100 in 1 BOTTLETABLET, FILM COATED10026
55301-175-12Acetaminophen100 in 1 BOTTLETABLET, FILM COATED10026
55301-175-12Acetaminophen1 in 1 CARTONTABLET, FILM COATED126
55301-175-15Acetaminophen1 in 1 CARTONTABLET, FILM COATED126
55301-175-15Acetaminophen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5026
55301-175-60Acetaminophen200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20026
55301-175-95Acetaminophen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1026

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-175ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]25Current NDC, Legacy NDC, 10 package rows20250406_26ae0d0a-34c0-4d16-951a-8d5a463c808b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN26ae0d0a-34c0-4d16-951a-8d5a463c808b26
198440acetaminophen 500 MG Oral TabletSCD26ae0d0a-34c0-4d16-951a-8d5a463c808b26
198440APAP 500 MG Oral TabletSY26ae0d0a-34c0-4d16-951a-8d5a463c808b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-175-03553010175031 BOTTLE, PLASTIC in 1 CARTON (55301-175-03) > 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
55301-175-06553010175062 in 1 CARTONHistorical
55301-175-1255301017512100 in 1 BOTTLEHistorical
55301-175-15553010175151 BOTTLE, PLASTIC in 1 CARTON (55301-175-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
55301-175-6055301017560200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-175-60) 1993-04-020000-00-00NoNoCurrent
55301-175-955530101759510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-175-95) 1993-04-02NoNoCurrent