Acetaminophen Gelcaps

Product NDC: 41163-520
11-digit product format: 411630520
Labeler code: 41163
Product ID: 41163-520_24b1c980-fa47-ab5b-e063-6394a90ab3be
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-01
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-520	41163-520-02	D	Discontinued by firm		2026-10-15
excluded package	package	41163-520	41163-520-07	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41163-520-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-520-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-520-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-520-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-520-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-520-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-520-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-520-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-520-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-520-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-520-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-520-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-520-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-520-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-520-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-520-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-520-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-520-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-520-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-520-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-520-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-520-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-520-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-520-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Gelcaps
Brand name suffix: Extra Strength
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
3588a3ef-a493-43ed-96e0-c259f0d087db	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	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
41163-520-01	Acetaminophen GelcapsExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
41163-520-01	Acetaminophen GelcapsExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	5
41163-520-02	Acetaminophen GelcapsExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	5
41163-520-02	Acetaminophen GelcapsExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
41163-520-03	Acetaminophen GelcapsExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
41163-520-03	Acetaminophen GelcapsExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	5
41163-520-07	Acetaminophen GelcapsExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
41163-520-07	Acetaminophen GelcapsExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, COATED	150	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-520-01	EA - Each	41163-520	da3592e4-1207-485a-9c7c-d5e281f8140c	1	2017-03-06
41163-520-03	EA - Each	41163-520	4b802a2a-d722-4502-b07c-e1717b6b3a64	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-520	ACETAMINOPHEN GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	5	Current NDC, Legacy NDC, 8 package rows	20241019_3588a3ef-a493-43ed-96e0-c259f0d087db.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 28 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXIMUM STRENGTH NON-ASPIRIN 100	ACETAMINOPHEN	JHK Inc dba American Safety & First Aid	1d3e9948-883e-4668-9bb8-d699a283b51a	2025-12-16	Warnings	Exact identifier application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIX	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	fa951d50-b79c-4161-8c81-fcf386b0964e	2025-12-15	Warnings	Exact identifier application number: M013
Vanquish Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	DSE Healthcare Solutions, LLC	cbf12223-ef44-494b-9d3c-971dce3c5ade	2025-12-15	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8bc75bcf-01c9-41d0-a96f-77a24e3edf01	2025-12-15	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREENS	40a1b354-9b2e-1cf3-e063-6394a90af113	2025-12-13	Warnings	Exact identifier application number: M013
topcare childrens pain and fever	ACETAMINOPHEN	Topco Associates LLC	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	2025-12-13	Warnings	Exact identifier application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-Eleven	ACETAMINOPHEN TABLET	Lil' Drug Store Products, Inc.	45c397bd-a1ff-1246-e063-6394a90ac54a	2025-12-12	Warnings	Exact identifier application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45c7c11b-d627-aee8-e063-6294a90a401d	2025-12-12	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	TOP CARE (Topco Associates LLC)	d3df90be-9037-44b2-bf48-540d68a033b2	2025-12-12	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Hy-Vee	98ab6fb7-c7e5-45ab-97c3-81d422f8a843	2025-12-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	33599f18-5f49-4f22-8a77-a072115763ef	2025-12-11	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	VALU MERCHANDISERS COMPANY	746059b3-ed18-4a81-a70e-4d758e048d8e	2025-12-11	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f8820150-feec-4062-85bb-14525ddf691f	2025-12-11	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	005e299e-aa84-49d9-bbca-12236f865a27	2025-12-11	Warnings	Exact identifier application number: M013
Low Dose Chewable Aspirin	ASPIRIN	VALU MERCHANDISERS COMPANY	7d88f156-d361-4249-b70d-4bbcd5ba30b7	2025-12-11	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin	ASPIRIN	VALU MERCHANDISERS COMPANY	cc18e8e1-652e-44da-a9d7-e56cebda55a1	2025-12-11	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d4c32e70-778a-4d66-b9d0-03944a528421	2025-12-11	Warnings	Exact identifier application number: M013
adult low dose aspirin	ASPIRIN	VALU MERCHANDISERS COMPANY	6fa1c707-bd42-455b-90a3-2c2a11acc683	2025-12-11	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	5a80cb17-7731-4457-acd3-64cf4accf862	2025-12-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	02e3798f-86d9-64b4-e063-6294a90a29de	2025-12-11	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	3588a3ef-a493-43ed-96e0-c259f0d087db	5
198440	acetaminophen 500 MG Oral Tablet	SCD	3588a3ef-a493-43ed-96e0-c259f0d087db	5
198440	APAP 500 MG Oral Tablet	SY	3588a3ef-a493-43ed-96e0-c259f0d087db	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-520-01	41163052001	1 BOTTLE, PLASTIC in 1 CARTON (41163-520-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-11-01	0000-00-00	No	No	Current
41163-520-02	41163052002	50 in 1 BOTTLE, PLASTIC					Historical
41163-520-03	41163052003	1 BOTTLE, PLASTIC in 1 CARTON (41163-520-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-10-01	0000-00-00	No	No	Current
41163-520-07	41163052007	1 in 1 CARTON					Historical