FDA.reportPublic FDA data

Acetaminophen

Product NDC
70000-0410
11-digit product format
700000410
Labeler code
70000
Product ID
70000-0410_56bd09ea-9506-021f-e063-6394a90a62f0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-05
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c342ae6-5de6-5c2f-e053-2a91aa0a3f0dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0410-1Acetaminophen60 in 1 BOTTLETABLET608
70000-0410-1Acetaminophen1 in 1 CARTONTABLET18
70000-0410-2Acetaminophen100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0410-1EA - Each70000-0410b378b90c-e815-4422-a695-d839397a17e812019-08-06
70000-0410-2EA - Each70000-0410c93aa3f3-999c-4358-a756-ec1735f4d1ca12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0410ACETAMINOPHEN TABLET [LEADER/ CARDINAL HEALTH 110, INC.]8Current NDC, Legacy NDC, 3 package rows20250122_7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d.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 39 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Extra Strength APAPACETAMINOPHENUnifirst First Aid Corporationf77f8ef5-4aa8-fa80-e053-6394a90a70c22025-09-08WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINEUnifirst First Aid Corporationc2d7af6b-f477-2462-e053-2995a90aff0f2025-09-08WarningsExact identifier
application number: M013
Medique Extra Strength ApapACETAMINOPHENUnifirst First Aid Corporation14bcbaf9-76b6-f8ba-e063-6294a90a91f62025-09-08WarningsExact identifier
application number: M013
Crane Safety XS Non-AspirinACETAMINOPHEN 500 MGCrane Safety LLC9626b3b2-c8ba-5a58-e053-2995a90a35c82025-09-08WarningsExact identifier
application number: M013
Thompson AspirinASPIRINThompson9623d9c6-f241-bf4a-e053-2a95a90a4eb52025-09-08WarningsExact identifier
application number: M013
Thompson XS Pain AcheASPIRIN, CAFFEINEThompson Safetye87c2874-2a95-6839-e053-2a95a90ad14b2025-09-08WarningsExact identifier
application number: M013
Medique at Home APAPACETAMINOPHENUnifirst First Aid Corporationb5582e23-5079-1f2b-e053-2a95a90ad8002025-09-08WarningsExact identifier
application number: M013
Thompson Extra Strength Non-AspirinACETAMINOPHENThompsonf837c31f-24e5-a8df-e053-6394a90a0b362025-09-08WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLC64c642b7-ef83-44b7-a014-6fa248dff3ba2025-09-08WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINEBJWC (Berkley & Jensen / BJ's)2f473f1f-7cf3-2af5-e063-6394a90aaa172025-09-01WarningsExact identifier
application number: M013
foster and thrive rapid release pain reliefACETAMINOPHENStrategic Sourcing Services LLCd2130173-b107-4ae6-a1f7-6db467da38202025-08-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.e1d4f562-433c-4344-9b77-1a7c731d1be52025-08-29WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENSafeway0e0a73f9-8c18-41fd-812e-8be20287e77a2025-08-26WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINBJWC (Berkley & Jensen / BJ's)577035a5-88ab-431c-8598-7a19dd633fe92025-08-26WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENSixarp, LLC2e20be17-2b6c-1a07-e063-6394a90acdd32025-08-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINBJWC (Berkley & Jensen / BJ's)2f32b096-d29a-c7c7-e063-6294a90a2bbe2025-08-22WarningsExact identifier
application number: M013
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPublix Super Markets Inc6b691dc1-09e4-46d3-b199-8917e42848a62025-08-19WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENP & L Development, LLC59eb14a5-40b0-4331-beb5-7166e6cdf4112025-08-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d8
198440acetaminophen 500 MG Oral TabletSCD7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d8
198440APAP 500 MG Oral TabletSY7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0410-1700000410011 BOTTLE in 1 CARTON (70000-0410-1) / 60 TABLET in 1 BOTTLE1 bottle2018-12-190000-00-00NoNoCurrent
70000-0410-270000041002100 TABLET in 1 BOTTLE (70000-0410-2) 100 tablet2018-11-050000-00-00NoNoCurrent