Feverall

Product NDC: 51672-2114
Requested package NDC: 51672-2114-4
11-digit product format: 516722114
Labeler code: 51672
Product ID: 51672-2114_575ce0e3-78a7-b636-e063-6294a90aba2d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA018337
Marketing category: NDA
Marketing start: 2013-12-12
Substance: ACETAMINOPHEN
Active strength: 80 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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N018337-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982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N018337-001	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`84e616aacf4f…`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.

Additional Listing Data#

Finished product: Yes
Brand name base: Feverall
Brand name suffix: Infants
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	80 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198445	Internal RxNorm lookup
209531	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
3ade895b-5dca-4d81-9415-8091923162ff	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
51672-2114-0	Feverall Infants	1 in 1 BLISTER PACK	SUPPOSITORY	1	7
51672-2114-2	Feverall Infants	6 in 1 CARTON	SUPPOSITORY	6	7
51672-2114-4	Feverall Infants	50 in 1 CARTON	SUPPOSITORY	50	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2114-0	EA - Each	51672-2114	22895600-28c0-4bbd-903a-c51f2fc07249	1	2015-04-03
51672-2114-2	EA - Each	51672-2114	1a9d2dc2-b455-4e32-921e-f10c5884362c	1	2014-09-03
51672-2114-4	EA - Each	51672-2114	dd2410f8-5265-4bfd-abab-acac85db7608	1	2014-09-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2114	FEVERALL INFANTS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]	6	Current NDC, Legacy NDC, 3 package rows	20241212_3ade895b-5dca-4d81-9415-8091923162ff.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 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 ndc (package): 51672-2114-4 ndc (product): 51672-2114 ndc11 (package): 51672211404

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
198445	acetaminophen 80 MG Rectal Suppository	PSN	3ade895b-5dca-4d81-9415-8091923162ff	7
209531	Feverall Infants 80 MG Rectal Suppository	PSN	3ade895b-5dca-4d81-9415-8091923162ff	7
209531	acetaminophen 80 MG Rectal Suppository [Feverall]	SBD	3ade895b-5dca-4d81-9415-8091923162ff	7
198445	acetaminophen 80 MG Rectal Suppository	SCD	3ade895b-5dca-4d81-9415-8091923162ff	7
198445	APAP 80 MG Rectal Suppository	SY	3ade895b-5dca-4d81-9415-8091923162ff	7
209531	APAP 80 MG Rectal Suppository [Feverall]	SY	3ade895b-5dca-4d81-9415-8091923162ff	7
209531	Feverall Infants 80 MG Rectal Suppository	SY	3ade895b-5dca-4d81-9415-8091923162ff	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2114-4	51672211404	50 BLISTER PACK in 1 CARTON (51672-2114-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)	50 blister pack	2013-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Feverall ® Infants'	Sun Pharmaceutical Industries, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2026-07-24	HUMAN OTC DRUG LABEL	8