Home NDC 0713-0118 ACEPHEN
Product NDC 0713-0118
11-digit product format 007130118
Labeler code 0713
Product ID 0713-0118_3165c71f-98a6-4838-998e-a90dcc7a9515
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA018060
Marketing category NDA
Marketing start 1982-01-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 120 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018060-001 ACEPHEN ACETAMINOPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 N018060-002 ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 N018060-003 ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18
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 4 · 129 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 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018060-002 ACEPHEN 650MG SUPPOSITORY / RECTAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018060-003 ACEPHEN 325MG SUPPOSITORY / RECTAL 1986-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018060-001 ACEPHEN 120MG SUPPOSITORY / RECTAL Approved before 1982 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Butylated Hydroxyanisole INACTIVE INGREDIENT REK4960K2U ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Hydrogenated Coconut Oil INACTIVE INGREDIENT JY81OXM1OM ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Peg-100 Stearate INACTIVE INGREDIENT YD01N1999R ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.] 5 Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Butylated Hydroxyanisole INACTIVE INGREDIENT REK4960K2U ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Hydrogenated Coconut Oil INACTIVE INGREDIENT JY81OXM1OM ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Peg-100 Stearate INACTIVE INGREDIENT YD01N1999R ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ACETAMINOPHEN SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 1
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 0713-0118-01 00713011801 100 SUPPOSITORY in 1 BOX (0713-0118-01) 100 suppository 1982-01-01 0000-00-00 No No Current 0713-0118-12 00713011812 12 SUPPOSITORY in 1 BOX (0713-0118-12) 12 suppository 1982-01-01 0000-00-00 No No Current 0713-0118-50 00713011850 50 SUPPOSITORY in 1 BOX (0713-0118-50) 50 suppository 1982-01-01 0000-00-00 No No Current