Direct Safety Extra Strength Aspirin Free

Product NDC: 61245-175
11-digit product format: 612450175
Labeler code: 61245
Product ID: 61245-175_3e5d7595-9e65-3fd6-e063-6394a90a6f80
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Conney Safety Products, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-31
Substance: ACETAMINOPHEN
Active strength: 500 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: Direct Safety Extra Strength Aspirin Free
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 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
198440	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
a524c36a-38f3-4266-8f45-589e19400328	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61245-175-13	Direct Safety Extra Strength Aspirin Free	250 in 1 BOX	TABLET, FILM COATED	250		11
61245-175-13	Direct Safety Extra Strength Aspirin Free	2 in 1 PACKET	TABLET, FILM COATED	2		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61245-175	DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20241030_a524c36a-38f3-4266-8f45-589e19400328.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 48 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	CVS HEALTH CORP	bbc48c9e-7eb8-2c67-e053-2a95a90a8552	2025-02-13	Warnings	Exact identifier application number: M013
Dye Free Infants Pain and Fever	ACETAMINOPHEN	CVS	1fde0f7c-4b5b-ae9c-e063-6394a90afa41	2025-02-13	Warnings	Exact identifier application number: M013
NOTTS - Extra Strength 500 mg	ACETAMINOPHEN	VIVUNT PHARMA LLC	e677f43d-b4ce-e5b0-e053-2a95a90ad67e	2025-02-12	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	LEADER/ Cardinal Health 110, Inc.	b3773f02-02a9-33c8-e053-2995a90a2235	2025-02-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	c9f80d24-bd05-e1ce-e053-2995a90aa646	2025-02-10	Warnings	Exact identifier application number: M013
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c55aa-9932-0a55-e053-2a95a90a3d1e	2025-02-10	Warnings	Exact identifier application number: M013
AeroTab Pain Reliever	PAIN RELIEVER	Aero Healthcare	40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f	2025-02-10	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin Regular Strength	ASPIRIN	Time-Cap Labs, Inc	5fbd8bb3-46f9-4089-9a21-b6af97a06106	2025-02-08	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABS INC	c193dbc0-cc80-4a7c-aa29-457a20edf835	2025-02-08	Warnings	Exact identifier application number: M013
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	22f23aeb-f874-6e54-e063-6394a90a9565	2025-02-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3008928-c555-64ad-e053-2995a90a7307	2025-02-05	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300dfbc-7137-79d1-e053-2995a90a636e	2025-02-05	Warnings	Exact identifier application number: M013
Low dose aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300c30b-ab1a-a1b4-e053-2a95a90a1294	2025-02-05	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d174187-cf89-41ff-9a64-10e0276daf17	2025-02-05	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Bryant Ranch Prepack	c226205d-7c3c-49af-b3e2-fc7b09ad7857	2025-02-05	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	a69fca9d-c0a0-4321-bf03-5c8e99cc07cc	2025-02-04	Warnings	Exact identifier application number: M013
TENSION HEADACHE RELIEF	ACETAMINOPHEN-CAFFEINE	TARGET CORPORATION	8ed1679d-d3a1-11b1-e053-2995a90a61ad	2025-01-31	Warnings	Exact identifier application number: M013
ValuMeds Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cabinet Health P.B.C.	0f864e73-e4b8-4e23-8990-8439ac17bd58	2025-01-31	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN TABLETS 500 MG	WALGREENS	c25bfe92-0196-0489-e053-2995a90abea1	2025-01-30	Warnings	Exact identifier application number: M013
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c3524-3e24-3410-e053-2995a90a73ed	2025-01-30	Warnings	Exact identifier application number: M013

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
198440	acetaminophen 500 MG Oral Tablet	PSN	a524c36a-38f3-4266-8f45-589e19400328	11
198440	acetaminophen 500 MG Oral Tablet	SCD	a524c36a-38f3-4266-8f45-589e19400328	11
198440	APAP 500 MG Oral Tablet	SY	a524c36a-38f3-4266-8f45-589e19400328	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61245-175-13	61245017513	250 PACKET in 1 BOX (61245-175-13) / 2 TABLET, FILM COATED in 1 PACKET	250 packet	2013-05-31	0000-00-00	No	No	Current