EXTRA STRENGTH PAIN RELIEF

Product NDC: 68788-8375
11-digit product format: 687888375
Labeler code: 68788
Product ID: 68788-8375_87ba6c74-963f-4b18-b22e-5577a701daf7
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: 343
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-24
Substance: ACETAMINOPHEN
Active strength: 500 mg/15mL
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: EXTRA STRENGTH PAIN RELIEF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/15mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e18294f5-8fd5-4ac6-802c-f6d257e8bee7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8375-2	EXTRA STRENGTH PAIN RELIEF	237 mL in 1 BOTTLE	SUSPENSION	237		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8375-2	ML - Milliliter	68788-8375	fb709055-e992-4044-855b-ee62005cc0da	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8375	EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 1 package rows	20250509_e18294f5-8fd5-4ac6-802c-f6d257e8bee7.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
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	e18294f5-8fd5-4ac6-802c-f6d257e8bee7	2026-04-15	Warnings	Exact identifier ndc (product): 68788-8375

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8375-2	68788837502	237 mL in 1 BOTTLE (68788-8375-2)	237 ml	2023-02-24	No	No	Current