Home NDC 68071-4860 Acetaminophen
Product NDC 68071-4860
11-digit product format 680714860
Labeler code 68071
Product ID 68071-4860_1ae1a5f4-8419-25d8-e063-6294a90a35c6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-09
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4860-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4860-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4860-4 1332a3947898…d4bfe170f9cd…
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 Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4860-4 Acetaminophen 118 mL in 1 BOTTLE SUSPENSION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4860 ACETAMINOPHEN SUSPENSION [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240701_872365ca-0c6b-550a-e053-2a91aa0ab25a.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 26 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 69271b7a-18c0-4445-8164-cb1620fb5475 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 40bd7406-7ee6-47fe-8481-0a4c8cefce65 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 43194fe1-87a1-4ffa-ad73-a1dcec91fd63 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. b0b3ab27-704a-44b8-8473-d21ac3359ba1 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 39f64f10-f442-45a9-a060-9f99e78c678d 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. ed5a294a-fc03-43dd-825d-23a232060900 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. be558e5b-cf35-4035-a69c-8d66deeac6b2 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. a2591a96-ed66-45b1-abf6-6b26d0bb4f44 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. efe92e48-5086-4b61-a298-0d8ceefe100e 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022
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 68071-4860-4 68071486004 118 mL in 1 BOTTLE (68071-4860-4) 118 ml 2019-04-22 0000-00-00 No No Current