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 |
|---|---|---|---|---|---|---|
| Equaline Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | United Natural Foods, Inc. dba UNFI | 739237a5-cc62-8ad6-e053-2991aa0a91f8 | 2024-12-17 | Warnings | M013 |
| NOTTS - Muscle Aches and Pain | ACETAMINOPHEN | VIVUNT PHARMA LLC | e6741300-4573-2580-e053-2a95a90a599c | 2024-12-17 | Warnings | M013 |
| Extra Strength Pain Reliever, Caseys 4good | ACETAMINOPHEN 500MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fc5340-c224-e02b-e053-2a95a90a5297 | 2024-12-16 | Warnings | M013 |
| Pain Reliever, Caseys 4good | ACETAMINOPHEN 500 MG, TABLET | Lil' Drug Store Products, Inc. | 039d2cf1-57f6-4d9d-e063-6394a90a5492 | 2024-12-16 | Warnings | M013 |
| Extra Strength Headache, Caseys 4good | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0425c6a8-a3ea-24ad-e063-6294a90ae15a | 2024-12-16 | Warnings | M013 |
| Lil Drug Store Childrens Pain and Fever | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | 5fcd41ad-449f-4090-be19-eae4171de891 | 2024-12-16 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e75551-1e50-9896-e053-2a95a90aafd4 | 2024-12-14 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | M013 |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 2928e140-c868-5bf5-e063-6394a90ab024 | 2024-12-13 | Warnings | M013 |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | M013 |
| Rite Aid Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Rite Aid | b4797380-9cef-d640-e053-2a95a90a0665 | 2024-12-11 | Warnings | M013 |
| Top Value Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE | Tower Laboratories Ltd | 44babed8-cf38-1c12-e054-00144ff8d46c | 2024-12-11 | Warnings, Adverse reactions | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | b5e2300a-b77b-53cc-e053-2a95a90a7a6e | 2024-12-11 | Warnings | M013 |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | M013 |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6feff0a-3347-194d-e053-2a95a90acd20 | 2024-12-05 | 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 |