EXTRA PAIN RELIEF

Product NDC: 49483-370
11-digit product format: 494830370
Labeler code: 49483
Product ID: 49483-370_39a1157a-bfc7-63f5-e063-6394a90a9bba
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABS
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-11-01
Substance: ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength: 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
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: EXTRA PAIN RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	250 mg/1
ASPIRIN	250 mg/1
CAFFEINE	65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308297	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
59482917-f80b-4bed-9218-068b35366eb3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
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
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	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
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-370-00	EXTRA PAIN RELIEF	20000 in 1 CARTON	TABLET, FILM COATED	20000	8
49483-370-01	EXTRA PAIN RELIEF	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	8
49483-370-20	EXTRA PAIN RELIEF	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	8
49483-370-31	EXTRA PAIN RELIEF	300 in 1 BOTTLE	TABLET, FILM COATED	300	8
49483-370-42	EXTRA PAIN RELIEF	1 in 1 CARTON	TABLET, FILM COATED	1	8
49483-370-42	EXTRA PAIN RELIEF	24 in 1 BOTTLE	TABLET, FILM COATED	24	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-370	EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]	7	Current NDC, Legacy NDC, 6 package rows	20240316_59482917-f80b-4bed-9218-068b35366eb3.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 73 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	9c7d65e4-df2f-47c1-a185-66aaf19aad2b	2024-02-01	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	57e4820c-b4eb-442e-9c49-93eedfbc5e5e	2024-02-01	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	Proficient Rx LP	73013074-9c6e-43c7-acde-4d9d8ed0133d	2024-02-01	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Proficient Rx LP	c466a07f-2339-4cf5-8377-e0f109649c52	2024-02-01	Warnings	Exact identifier application number: M013
Percogesic Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE	Medtech Products Inc.	2c5f1140-fb83-42c9-b0b1-5e2bd69340bb	2024-02-01	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Proficient Rx LP	3c7783a7-2b28-4968-b766-0a49dc70ce6d	2024-02-01	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	102bdcde-cb90-f248-e063-6394a90aac79	2024-01-30	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	61802b27-c9ec-4386-9d44-45e8b1e558b7	2024-01-28	Warnings	Exact identifier application number: M013
AGRIFEN	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	0fde22da-cdfc-36cc-e063-6294a90a3885	2024-01-26	Warnings	Exact identifier application number: M013
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	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
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	59482917-f80b-4bed-9218-068b35366eb3	8
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	59482917-f80b-4bed-9218-068b35366eb3	8
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	59482917-f80b-4bed-9218-068b35366eb3	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-370-00	49483037000	20000 TABLET, FILM COATED in 1 CARTON (49483-370-00)		2016-02-22	0000-00-00	No	No	Current
49483-370-01	49483037001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-01)		2021-07-16	0000-00-00	No	No	Current
49483-370-20	49483037020	200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-20)		2013-11-01	0000-00-00	No	No	Current
49483-370-31	49483037031	300 TABLET, FILM COATED in 1 BOTTLE (49483-370-31)		2024-03-15		No	No	Current
49483-370-42	49483037042	1 BOTTLE in 1 CARTON (49483-370-42) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen 250 mg, Aspirin 250 mg (NSAID), and Caffeine 65 mg Tablets	TIME CAP LABS \| MARKSANS PHARMA LIMITED	2025-07-11	HUMAN OTC DRUG LABEL	8
EXTRA PAIN RELIEF	Apace Packaging, LLC \| Time Cap Laboratories, Inc.	2018-11-13	HUMAN OTC DRUG LABEL	2