Home NDC 51672-2115 Feverall
Product NDC 51672-2115
11-digit product format 516722115
Labeler code 51672
Product ID 51672-2115_59cc44c6-9464-1e04-e063-6394a90a7466
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 120 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 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N018337-001 ACETAMINOPHEN ACETAMINOPHEN 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUPPOSITORY / RECTAL RLD, Approved before 1982 N018337-002 ACETAMINOPHEN ACETAMINOPHEN 325MG SUPPOSITORY / RECTAL RLD,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 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 Product TE source text 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N018337-001 ACETAMINOPHEN 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUPPOSITORY / RECTAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018337-002 ACETAMINOPHEN 325MG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 Childrens
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 120 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 198434 Internal RxNorm lookup 209353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-2115-0 Feverall Childrens 1 in 1 BLISTER PACK SUPPOSITORY 1 7 51672-2115-2 Feverall Childrens 6 in 1 CARTON SUPPOSITORY 6 7 51672-2115-4 Feverall Childrens 50 in 1 CARTON SUPPOSITORY 50 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2115 FEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.] 6 Current NDC, Legacy NDC, 3 package rows 20241211_861e2987-5473-45b0-b2a6-f980a9b0e809.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-2115-0 51672211500 1 in 1 BLISTER PACK Historical 51672-2115-2 51672211502 6 BLISTER PACK in 1 CARTON (51672-2115-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) 6 blister pack 2013-12-12 0000-00-00 No No Current 51672-2115-4 51672211504 50 BLISTER PACK in 1 CARTON (51672-2115-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) 50 blister pack 2013-12-12 0000-00-00 No No Current