Feverall

Manufacturer: Sun Pharmaceutical Industries, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC
Effective date: 2026-07-24
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: daily-update
Hydrated at: 2026-08-26 01:01:42

Label at a glance#

ProductFeverall Infants

Active ingredientACETAMINOPHEN

Label structure11 sections

Indications and uses

temporarily reduces fever relieves minor aches, pains, and headache

Dosage and administration

this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 months Do not use unless directed by a doctor 6 to 11 months Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours) 12 to 36 months Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Storage and handling

store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged

Contacts and useful links#

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 80 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily

reduces fever
relieves minor aches, pains, and headache

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
with other drugs containing acetaminophen

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to acetaminophen.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

the child has liver disease.
the child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

fever lasts more than 3 days (72 hours), or recurs.
pain lasts more than 3 days or gets worse.
new symptoms occur.
redness or swelling is present in the painful area.

These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

this product does not contain directions or warnings for adult use
do not use more than directed
remove wrapper
carefully insert suppository well up into the rectum

Dosing Chart
Age	Dose
under 6 months	Do not use unless directed by a doctor
6 to 11 months	Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
12 to 36 months	Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information

STORAGE AND HANDLING SECTION

store at 2°-27°C (35°-80°F)
do not use if imprinted suppository wrapper is opened or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Dist. by: Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 6 Suppository Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2114-2

FeverAll _® ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6 Rectal Suppositories

80 mg each

Carton

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0351672211424	GTIN-13: 0351672211424 EAN-13: 0351672211424 GTIN-12: 351672211424 UPC-A: 351672211424 GTIN storage (14 digits): 00351672211424	FEVERALL carton 80mg 6 ct.jpg

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 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	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	2
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	2
hydrogenated palm kernel oil	INACTIVE INGREDIENT	FM8D1RE2VP	2
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Feverall Infants
Acetaminophen
GLYCERYL MONOSTEARATE
HYDROGENATED PALM KERNEL OIL
PEG-100 STEARATE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-2114	51672-2114-0, 51672-2114-2, 51672-2114-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROGENATED PALM KERNEL OIL	FM8D1RE2VP	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2026-02-02	full-release	2026-06-01 01:36:16

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`c2088c7a36db…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Feverall Infants	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3ade895b-5dca-4d81-9415-8091923162ff	2026-07-24	Warnings	Exact identifier ndc (package): 51672-2114-4 ndc (package): 51672-2114-0 ndc (package): 51672-2114-2 ndc (product): 51672-2114 ndc11 (package): 51672211404 ndc11 (package): 51672211400 ndc11 (package): 51672211402 spl id: 575ce0e3-78a7-b636-e063-6294a90aba2d spl set id: 3ade895b-5dca-4d81-9415-8091923162ff

Reported adverse events (FAERS/openFDA)#

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