Home NDC 49580-0282-4 Pain and Fever
Product NDC 49580-0282
Requested package NDC 49580-0282-4
11-digit product format 495800282
Labeler code 49580
Product ID 49580-0282_d2a041fc-599a-48bb-8582-045c61473752
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler P & L Development, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-05-31
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Pain and Fever
Brand name suffix Childrens
Listing expiration 2027-12-31 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0282-2 Pain and FeverChildrens 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 7 49580-0282-4 Pain and FeverChildrens 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 7 49580-0282-4 Pain and FeverChildrens 1 in 1 BOX SUSPENSION 1 7 49580-0282-8 Pain and FeverChildrens 1 in 1 BOX SUSPENSION 1 7 49580-0282-8 Pain and FeverChildrens 237 mL in 1 BOTTLE, PLASTIC SUSPENSION 237 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0282 PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC] 6 Current NDC, Legacy NDC, 5 package rows 20240217_b815fcae-8bba-4737-ac10-29a32fb69275.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 45 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN A-S Medication Solutions c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 2025-04-24 Warnings Exact identifier application number: M013 Extra Strength No-Pain ACETAMINOPHEN Safrel Pharmaceuticals, LLC. 873f01dd-0701-5fd3-e053-2a95a90a6463 2025-04-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Chain Drug Consortium 60d4b392-6ed0-4115-8154-24eaf72504a5 2025-04-16 Warnings Exact identifier application number: M013 Premsyn pms Premenstrual Pain Relief ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE Focus Consumer Healthcare, LLC 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 2025-04-14 Warnings Exact identifier application number: M013 BackAid Max ACETAMINOPHEN, PAMABROM Kobayashi Healthcare International, Inc. fb9a5647-b7c9-4820-b148-91060e34cb83 2025-04-14 Warnings Exact identifier application number: M013 RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49580-0282-4 49580028204 1 BOTTLE, PLASTIC in 1 BOX (49580-0282-4) / 118 mL in 1 BOTTLE, PLASTIC 2016-05-31 0000-00-00 No No Current