infants pain and fever
- Product NDC
- 59779-590
- 11-digit product format
- 597790590
- Labeler code
- 59779
- Product ID
- 59779-590_a34699ac-20ae-4ca6-a2c0-20003a0c42e7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1993-04-30
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59779-590 | 59779-590-10 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 59779-590 | 59779-590-26 | D | Discontinued by firm | 2026-10-21 |
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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-590-26 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-590-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-590-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-590-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-590-26 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-590-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-590-26 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-590-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-590-26 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-590-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-590-26 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-590-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-590-26 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-590-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-590-26 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-590-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-590-26 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-590-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-590-26 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-590-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-590-26 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-590-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-590-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-590-26 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- infants pain and fever
- 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 |
|---|---|
| 53b06c48-598e-41ad-ac7a-5508c195535c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-590-10 | infants pain and fever | 30 mL in 1 BOTTLE | SUSPENSION | 30 | 6 | |
| 59779-590-10 | infants pain and fever | 1 in 1 CARTON | SUSPENSION | 1 | 6 | |
| 59779-590-16 | infants pain and fever | 1 in 1 CARTON | SUSPENSION | 1 | 6 | |
| 59779-590-16 | infants pain and fever | 59 mL in 1 BOTTLE | SUSPENSION | 59 | 6 | |
| 59779-590-26 | infants pain and fever | 1 in 1 CARTON | SUSPENSION | 1 | 6 | |
| 59779-590-26 | infants pain and fever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-590-10 | ML - Milliliter | 59779-590 | b3aefd34-952f-4883-a470-6e51c3f1c3b8 | 1 | 2019-12-10 |
| 59779-590-16 | ML - Milliliter | 59779-590 | 6a643d92-775a-4564-b598-4e0b7309d720 | 1 | 2019-12-10 |
| 59779-590-26 | ML - Milliliter | 59779-590 | fd201fc1-bf62-47e8-9f31-0d0289d44580 | 1 | 2019-12-10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Westminster Pharmaceuticals, LLC | ace5ebac-ec11-4c26-b1e3-954b450ee671 | 2021-05-04 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 8cacf02c-9925-40d4-92bc-78788aa0681a | 2020-11-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN 500 MG | Allegiant Health | 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7 | 2020-03-13 | Warnings | M013 |
| Acetaminophen 500mg ES | ACETAMINOPHEN 500MG | Allegiant Health | 91acc132-01b6-467b-9af5-70f4dc93e087 | 2019-01-08 | Warnings | M013 |
| Acetaminophen 325mg RS | ACETAMINOPHEN 325MG | Allegiant Health | 61c6d281-e59b-4277-bbce-f71c12c2a56d | 2019-01-07 | Warnings | M013 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Allegiant Health | 9a4c0c43-a71a-4e22-a3d5-9eb9622689a2 | 2019-01-02 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | 423a8445-964c-4cdb-889a-f391ca5253e7 | 2018-12-31 | Warnings | M013 |
| Cold Multi-Symptom Night-time | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI | Allegiant Health | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 2018-12-26 | Warnings | M013 |
| Aspirin Chewable | ASPIRIN 81 MG | Allegiant Health | 92b8637b-03a9-461f-b2f6-6eddaa214953 | 2018-12-21 | Warnings | M013 |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Allegiant Health | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 2018-12-21 | Warnings | M013 |
| Clear Choice Regular Strength Pain Reliever | ACETAMINOPHEN | Athlete's Needs, Inc. | d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 | 2018-12-11 | Warnings | M013 |
| ASPIRIN Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 5910a882-eb40-440f-8a30-c21fbce9050e | 2018-11-07 | Warnings | M013 |
| Aspirin | ASPIRIN 325 MG | Allegiant Health | 88b54062-8b3d-4024-a957-62b3255184b9 | 2018-11-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 | 2018-11-07 | Warnings | M013 |
| Tension Headache Relief | TENSION HEADACHE RELIEF | Allegiant Health | b431a1a3-39c4-4d6c-afdc-c8b017ad89da | 2017-11-16 | Warnings | M013 |
| SED-MAX | ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG | Command Brands, LLC | 4920a0e9-6f88-4df0-8657-77c95a3b9617 | 2017-01-19 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 53b06c48-598e-41ad-ac7a-5508c195535c | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59779-590-10 | 59779059010 | 1 BOTTLE in 1 CARTON (59779-590-10) > 30 mL in 1 BOTTLE | 1 bottle | 2011-12-07 | 0000-00-00 | No | No | Current |
| 59779-590-16 | 59779059016 | 1 BOTTLE in 1 CARTON (59779-590-16) / 59 mL in 1 BOTTLE | 1 bottle | 2011-12-07 | 0000-00-00 | No | No | Current |
| 59779-590-26 | 59779059026 | 1 BOTTLE in 1 CARTON (59779-590-26) > 118 mL in 1 BOTTLE | 1 bottle | 2018-05-29 | 0000-00-00 | No | No | Current |