Indications and uses
temporarily reduces fever relieves minor aches, pains, and headache
temporarily reduces fever relieves minor aches, pains, and headache
do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 years do not use 6 to 12 years Use 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours) adults and children 12 years and older Use 2 suppositories every 4 to 6 hours. (maximum of 6 doses)
store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged
Drug Facts
Acetaminophen, USP 325 mg
Pain reliever/fever reducer
temporarily
This product contains acetaminophen.
Severe liver damage may occur if
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
For rectal use only.
These may be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use. 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.
| Age | Dose |
|---|---|
| under 6 years | do not use |
| 6 to 12 years | Use 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours) |
| adults and children 12 years and older | Use 2 suppositories every 4 to 6 hours. (maximum of 6 doses) |
glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80
call 1-866-923-4914
Dist. by:
Ohm Laboratories, Inc.
New Brunswick, NJ 08901
Tamper-evident: Suppositories are individually wrapped.
Do not use if imprinted wrapper is opened or damaged.
NDC 51672-2116-2
JR. STRENGTH
ages 6-12 years
FeverAll
®
ACETAMINOPHEN SUPPOSITORIES
Pain Reliever/Fever Reducer
6 Rectal Suppositories
325 mg each
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-2116-2 | EA - Each | 51672-2116 | fe61d879-44ce-47fd-bdf9-0adaffd7ae79 | 1 | 2014-09-03 |
| 51672-2116-4 | EA - Each | 51672-2116 | 8714140c-e1ea-469e-935e-2209831099f2 | 1 | 2014-09-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51672-2116 | 51672-2116-0, 51672-2116-2, 51672-2116-4 |
Every source-derived ingredient row is available through these pages.
| 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 |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2026-02-02 | full-release | 2026-06-01 01:36:16 |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| PEG-100 stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | 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 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.
| 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 | 51672-2116-4 51672-2116-2 51672-2116-0 51672-2116 51672211604 51672211600 51672211602 5a99e46d-4983-579f-e063-6394a90a40db 3561bbc3-53b0-4857-8b71-39e165ed95ce |
Adverse event summaries are temporarily unavailable. Other product information remains available.