LOW DOSE ASPIRIN

Product NDC: 49483-481
11-digit product format: 494830481
Labeler code: 49483
Product ID: 49483-481_0db42a3e-0e86-1b7c-e063-6294a90a59f5
Type: HUMAN OTC DRUG
Nonproprietary name: ASPIRIN
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-19
Substance: ASPIRIN
Active strength: 81 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
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: LOW DOSE ASPIRIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASPIRIN	81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R16CO5Y76E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308416	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
1acc8c1a-c746-4635-800c-de1ad758fce0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-481-00	LOW DOSE ASPIRIN	1000000 in 1 CARTON	TABLET, COATED	1000000	9
49483-481-10	LOW DOSE ASPIRIN	1000 in 1 BOTTLE, PLASTIC	TABLET, COATED	1000	9
49483-481-12	LOW DOSE ASPIRIN	120 in 1 BOTTLE, PLASTIC	TABLET, COATED	120	9
49483-481-31	LOW DOSE ASPIRIN	300 in 1 BOTTLE, PLASTIC	TABLET, COATED	300	9
49483-481-50	LOW DOSE ASPIRIN	500 in 1 BOTTLE	TABLET, COATED	500	9
49483-481-65	LOW DOSE ASPIRIN	365 in 1 BOTTLE	TABLET, COATED	365	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-481-10	EA - Each	49483-481	68c3b475-b23b-4a98-95f3-b88442ecc38e	1	2017-06-15
49483-481-12	EA - Each	49483-481	6d406952-771a-4b61-979e-0a5c9475bf61	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-481	LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [TIME CAP LABORATORIES, INC]	9	Current NDC, Legacy NDC, 6 package rows	20231230_1acc8c1a-c746-4635-800c-de1ad758fce0.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI	Pharmadel LLC	0ab11691-5b29-55fc-e063-6394a90aa328	2023-11-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	1e223faa-f6d0-4235-bc4c-6cfca84a5b0a	2023-11-17	Warnings	Exact identifier application number: M013
SanaTos X	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	85b8ef3d-7318-7f3b-e053-2991aa0a0777	2023-11-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8badbaad-eb35-4251-a779-00474819360d	2023-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	09935a74-34b0-0e7c-e063-6294a90a7c83	2023-11-07	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dd6396-93e9-1096-e053-6394a90af06d	2023-11-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	eb644e9e-36dc-5f84-e053-2a95a90affa5	2023-11-02	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	Proficient Rx LP	46527b1f-7515-44ce-b5cb-9d24223b9af1	2023-11-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Proficient Rx LP	af8b30a0-7a56-4557-8404-cc8059fcd6bc	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	f6dd387d-c768-9443-e053-6394a90aca14	2023-10-31	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	AMERIFOODS TRADING COMPANY	f6cec280-17a5-5c5d-e053-6394a90a81aa	2023-10-31	Warnings	Exact identifier application number: M013
Regular Strength Aspirin	ASPIRIN	CARDINAL HEALTH, INC.	8aaa82c6-b46b-25c5-e053-2a95a90a3793	2023-10-30	Warnings	Exact identifier application number: M013
SafeTynadol	ACETAMINOPHEN	Sinew Pharma Inc.	b956d527-7ea7-e084-e053-2a95a90a866d	2023-10-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Magno-Humphries, Inc.	9d2275c8-0c3d-d2b3-e053-2995a90a368e	2023-10-27	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fb3-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22d642-8aaf-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M013
ENTERIC COATED ASPIRIN	ASPIRIN	Magno-Humphries, Inc.	a7c02378-4213-4e57-aca2-2437ad02f786	2023-10-27	Warnings	Exact identifier application number: M013
Extraprin	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Magno-Humphries, Inc.	9d22cdc8-29c5-4273-e053-2a95a90ad0bf	2023-10-27	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	c321208c-f192-42c5-9454-e0df5d02d685	2023-10-26	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	d913d11f-c7a1-49d2-a2d3-9a29fc032806	102
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	64c28b38-23bb-4c7e-9c19-1d1f0d597528	102
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	d913d11f-c7a1-49d2-a2d3-9a29fc032806	102
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	64c28b38-23bb-4c7e-9c19-1d1f0d597528	102
308416	ASA 81 MG Delayed Release Oral Tablet	SY	d913d11f-c7a1-49d2-a2d3-9a29fc032806	102
308416	ASA 81 MG Delayed Release Oral Tablet	SY	64c28b38-23bb-4c7e-9c19-1d1f0d597528	102
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	64c28b38-23bb-4c7e-9c19-1d1f0d597528	102
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	d913d11f-c7a1-49d2-a2d3-9a29fc032806	102
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	100
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	100
308416	ASA 81 MG Delayed Release Oral Tablet	SY	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	100
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	100
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	12
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	12
308416	ASA 81 MG Delayed Release Oral Tablet	SY	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	12
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	12
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	1acc8c1a-c746-4635-800c-de1ad758fce0	9
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	ed9a71d6-a56e-416a-bb89-6d41307efc5a	9
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	1acc8c1a-c746-4635-800c-de1ad758fce0	9
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	ed9a71d6-a56e-416a-bb89-6d41307efc5a	9
308416	ASA 81 MG Delayed Release Oral Tablet	SY	1acc8c1a-c746-4635-800c-de1ad758fce0	9
308416	ASA 81 MG Delayed Release Oral Tablet	SY	ed9a71d6-a56e-416a-bb89-6d41307efc5a	9
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	1acc8c1a-c746-4635-800c-de1ad758fce0	9
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	ed9a71d6-a56e-416a-bb89-6d41307efc5a	9
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	e839bff7-779a-446d-8486-c0e0a1b6d665	8
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	e839bff7-779a-446d-8486-c0e0a1b6d665	8
308416	ASA 81 MG Delayed Release Oral Tablet	SY	e839bff7-779a-446d-8486-c0e0a1b6d665	8
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	e839bff7-779a-446d-8486-c0e0a1b6d665	8
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	a272bf44-54df-448a-8bff-e31f9488b416	5
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	a272bf44-54df-448a-8bff-e31f9488b416	5
308416	ASA 81 MG Delayed Release Oral Tablet	SY	a272bf44-54df-448a-8bff-e31f9488b416	5
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	a272bf44-54df-448a-8bff-e31f9488b416	5
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	bbdd898f-061d-4dda-a8af-8e4f01950a47	3
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	81b4deec-fe5f-b0f9-e053-2991aa0a1c54	3
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	6d5b2167-8afc-7b71-e053-2991aa0aedf0	3
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	bbdd898f-061d-4dda-a8af-8e4f01950a47	3
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	81b4deec-fe5f-b0f9-e053-2991aa0a1c54	3
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	6d5b2167-8afc-7b71-e053-2991aa0aedf0	3
308416	ASA 81 MG Delayed Release Oral Tablet	SY	bbdd898f-061d-4dda-a8af-8e4f01950a47	3
308416	ASA 81 MG Delayed Release Oral Tablet	SY	81b4deec-fe5f-b0f9-e053-2991aa0a1c54	3
308416	ASA 81 MG Delayed Release Oral Tablet	SY	6d5b2167-8afc-7b71-e053-2991aa0aedf0	3
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	bbdd898f-061d-4dda-a8af-8e4f01950a47	3
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	81b4deec-fe5f-b0f9-e053-2991aa0a1c54	3
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	6d5b2167-8afc-7b71-e053-2991aa0aedf0	3
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	eeebff27-b379-4818-8331-2aa06780f56e	2
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	eeebff27-b379-4818-8331-2aa06780f56e	2
308416	ASA 81 MG Delayed Release Oral Tablet	SY	eeebff27-b379-4818-8331-2aa06780f56e	2
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	eeebff27-b379-4818-8331-2aa06780f56e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-481-00	49483048100	1000000 TABLET, COATED in 1 CARTON (49483-481-00)	2015-06-19	0000-00-00	No	No	Current
49483-481-10	49483048110	1000 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-481-10)	2015-06-19	0000-00-00	No	No	Current
49483-481-12	49483048112	120 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-481-12)	2015-06-19	0000-00-00	No	No	Current
49483-481-31	49483048131	300 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-481-31)	2021-05-03	0000-00-00	No	No	Current
49483-481-50	49483048150	500 TABLET, COATED in 1 BOTTLE (49483-481-50)	2021-06-24	0000-00-00	No	No	Current
49483-481-65	49483048165	365 TABLET, COATED in 1 BOTTLE (49483-481-65)	2023-07-30		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TCL 481R TABLETS	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-04-15	HUMAN OTC DRUG LABEL	6
ASPIRIN 81MG DELAYED RELEASE TABLETS	NCS HealthCare of KY, LLC dba Vangard Labs	2025-02-27	HUMAN OTC DRUG LABEL	9
481R TCL 49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	Bryant Ranch Prepack	2024-10-18	HUMAN OTC DRUG LABEL	100
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	8
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	Bryant Ranch Prepack	2024-05-06	HUMAN OTC DRUG LABEL	5
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	Bryant Ranch Prepack	2024-01-18	HUMAN OTC DRUG LABEL	102
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	Bryant Ranch Prepack	2024-01-18	HUMAN OTC DRUG LABEL	102
481R TCL 49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	A-S Medication Solutions	2024-01-05	HUMAN OTC DRUG LABEL	12
481R TCL 49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	TIME CAP LABORATORIES, INC	2023-12-30	HUMAN OTC DRUG LABEL	9
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	A-S Medication Solutions	2022-06-28	HUMAN OTC DRUG LABEL	2
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	REMEDYREPACK INC.	2021-12-22	HUMAN OTC DRUG LABEL	1
481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS	A-S Medication Solutions	2021-06-14	HUMAN OTC DRUG LABEL	3
LOW DOSE ASPIRIN - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN OTC DRUG LABEL	3
LOW DOSE ASPIRIN - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN OTC DRUG LABEL	3
TCL 481R TABLETS	McKesson Corporation dba RX Pak	2021-02-03	HUMAN OTC DRUG LABEL	3
TCL 481R TABLETS	RPK Pharmaceuticals, Inc.	2020-12-24	HUMAN OTC DRUG LABEL	1
LOW DOSE ASPIRIN - Bryant Ranch Prepack	Bryant Ranch Prepack	2019-02-01	HUMAN OTC DRUG LABEL	3