Acetaminophen

Product NDC: 71610-238
Requested package NDC: 71610-238-65
11-digit product format: 716100238
Labeler code: 71610
Product ID: 71610-238_a14457be-2ebb-46db-96dd-ebceb51c077f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-05-01
Substance: ACETAMINOPHEN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313782	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
89134c3e-ec5b-4a57-952a-98d6c6cff7c2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-238-65	Acetaminophen	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-238-65	EA - Each	71610-238	5ea6d19d-952a-4145-b2e9-982e4a8c6d4f	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-238	ACETAMINOPHEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190305_89134c3e-ec5b-4a57-952a-98d6c6cff7c2.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Aphena Pharma Solutions - Tennessee, LLC	89134c3e-ec5b-4a57-952a-98d6c6cff7c2	2019-02-26	Warnings	Exact identifier ndc (package): 71610-238-65 ndc (product): 71610-238 ndc11 (package): 71610023865

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313782	acetaminophen 325 MG Oral Tablet	PSN	89134c3e-ec5b-4a57-952a-98d6c6cff7c2	1
313782	acetaminophen 325 MG Oral Tablet	SCD	89134c3e-ec5b-4a57-952a-98d6c6cff7c2	1
313782	APAP 325 MG Oral Tablet	SY	89134c3e-ec5b-4a57-952a-98d6c6cff7c2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-238-65	71610023865	100 TABLET in 1 BOTTLE (71610-238-65)	100 tablet	2019-02-13	0000-00-00	No	No	Current