Feverall

Product NDC: 51672-2117
11-digit product format: 516722117
Labeler code: 51672
Product ID: 51672-2117_c107ee4d-6fd8-4cd8-9f80-5d140801eaba
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Taro Pharmaceuticals U.S.A. Inc.
Application: NDA018337
Marketing category: NDA
Marketing start: 2013-12-12
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 product	product	51672-2117		D	Discontinued by firm		2026-10-05
excluded package	package	51672-2117	51672-2117-4	D	Discontinued by firm		2026-10-05

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-2117-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-2117-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-2117-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-2117-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-2117-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-2117-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-2117-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-2117-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-2117-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51672-2117-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51672-2117-4	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018337-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N018337-002	ACETAMINOPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N018337-003	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12
N018337-004	INFANTS' FEVERALL	ACETAMINOPHEN	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018337-001	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018337-001	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2117-4	EA - Each	51672-2117	25acdf84-331d-45d9-90a7-ae5a2fe27bac	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2
hydrogenated palm kernel oil	INACTIVE INGREDIENT	FM8D1RE2VP	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	FEVERALL ADULTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Feverall Jr. Strength	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3561bbc3-53b0-4857-8b71-39e165ed95ce	2026-09-03	Warnings	Exact identifier application applno (NDA): 018337 application number: NDA018337
Feverall Childrens	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	861e2987-5473-45b0-b2a6-f980a9b0e809	2026-08-24	Warnings	Exact identifier application applno (NDA): 018337 application number: NDA018337
Feverall Infants	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3ade895b-5dca-4d81-9415-8091923162ff	2026-07-24	Warnings	Exact identifier application applno (NDA): 018337 application number: NDA018337

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	Marketing end	Sample	Exclude flag	Status
51672-2117-4	51672211704	50 BLISTER PACK in 1 CARTON (51672-2117-4) > 1 SUPPOSITORY in 1 BLISTER PACK (51672-2117-0)	50 blister pack	2013-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Feverall ® Adults	Taro Pharmaceuticals U.S.A. Inc. \| G&W NC Laboratories, Inc.	2016-05-19	HUMAN OTC DRUG LABEL	6