Pain and Fever
- Product NDC
- 49580-0282
- 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 |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b815fcae-8bba-4737-ac10-29a32fb69275 | Available on FDA.report |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chewable Aspirin | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d68ea-7f25-881f-e053-2995a90aa47f | 2024-10-15 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d750e-5a85-77f5-e053-2995a90a6915 | 2024-10-15 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Walgreen Company | 9e08eb38-7538-4fa0-a0e1-047ab6cb1680 | 2024-10-15 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | PUBLIX SUPER MARKETS INC | 9e779cc6-4641-6132-e053-2a95a90a3493 | 2024-10-11 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | CHAIN DRUG CONSORTIUM | 5c1a3081-ae25-4895-bf76-ebcbb9fc8072 | 2024-10-11 | Warnings | M013 |
| Aspirin 81 MG | ASPIRIN | Meijer | b3e5711c-9529-4eec-871d-de8efa858b86 | 2024-10-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | MEIJER DISTRIBUTION INC | 9586e830-a285-4a07-8b34-969875442348 | 2024-10-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 2024-10-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | 5de40821-3218-4320-bf11-9493bf01d489 | 2024-10-11 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 475becec-1a56-4cfa-a0c5-562f8772adfb | 2024-10-11 | Warnings | M013 |
| Topcare Pain Relief | ACETAMINOPHEN | Topco Associates LLC | 6036c15b-1168-4103-9471-6a74a2140e53 | 2024-10-10 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 46d9d8cd-e3db-492c-9386-7e8255beff64 | 2024-10-08 | Warnings | M013 |
| dg health aspirin | ASPIRIN | Dolgencorp, LLC | 0ab34dc7-0110-4fc3-ae53-234e7d7bca3c | 2024-10-07 | Warnings | M013 |
| ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 19ba1fb6-22ea-488e-9e52-94c14ceb80d1 | 2024-10-07 | Warnings | M013 |
| foster and thrive aspirin | ASPIRIN | Strategic Sourcing Services LLC | 4d66a8a8-a1c1-4430-8845-21ae67700c39 | 2024-10-07 | Warnings | M013 |
| leader aspirin | ASPIRIN | Cardinal Health 110, LLC. dba Leader | ca603b12-e0f7-4d79-8e0d-4651a788ba9b | 2024-10-07 | Warnings | M013 |
| foster and thrive aspirin | ASPIRIN | McKesson Medical-Surgical, Inc. | e9342478-93d6-45de-948f-f4162ee675b2 | 2024-10-07 | Warnings | M013 |
| Maximum Strength Backache Relief | MAGNESIUM SALICYLATE | JHK DBA American Safety & First Aid | f8cbcd4e-cfad-4592-8774-52e681494c45 | 2024-10-07 | Warnings | M013 |
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Navajo Manufacturing Company Inc. | f70875ab-241c-4876-e053-6294a90a8092 | 2024-10-03 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Navajo Manufacturing Company Inc. | 86b6ac01-3866-4cd8-a1be-9babb6ff311b | 2024-10-02 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | b815fcae-8bba-4737-ac10-29a32fb69275 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49580-0282-2 | 49580028202 | 118 mL in 1 BOTTLE, PLASTIC (49580-0282-2) | 118 ml | 2016-05-31 | 0000-00-00 | No | No | Current |
| 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 | |
| 49580-0282-8 | 49580028208 | 1 BOTTLE, PLASTIC in 1 BOX (49580-0282-8) / 237 mL in 1 BOTTLE, PLASTIC | 2016-05-31 | 0000-00-00 | No | No | Current |