Adwe Feverx Acetaminophen Caplets, 500 mg
- Product NDC
- 71009-109
- 11-digit product format
- 710090109
- Labeler code
- 71009
- Product ID
- 71009-109_31a5e50a-d3b9-f512-e063-6394a90a8c10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurex Laboratories Limited Liability Company
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-09
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- 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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71009-109-01 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71009-109-01 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71009-109-01 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71009-109-01 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71009-109-01 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71009-109-01 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71009-109-01 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71009-109-01 | I | Inactivated by FDA | 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
- Adwe Feverx Acetaminophen Caplets, 500 mg
- Brand name suffix
- Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 948c5826-6f35-484d-bb3f-cecf6a4b5c13 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71009-109-01 | 2024-12-23 | C162847 | 48780-1 | f386c649-c0c3-0266-e053-dadaa90a7c1a | Adwe Feverx Acetaminophen Caplets, 500 mg |
| 71009-109-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-c0c3-0266-e053-dadaa90a7c1a | Adwe Feverx Acetaminophen Caplets, 500 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71009-109-01 | Adwe Feverx Acetaminophen Caplets, 500 mgExtra Strength | 100 in 1 BOTTLE | TABLET | 100 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71009-109 | ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUREX LABORATORIES LIMITED LIABILITY COMPANY] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250402_948c5826-6f35-484d-bb3f-cecf6a4b5c13.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 |
|---|---|---|---|---|---|---|
| TEXACLEAR PAIN RELIEVER | CAFFEINE, CHOLINE SALICYLATE | GM Pharmaceuticals, INC | 065bd10c-3bcf-486f-a49c-40544127007f | 2025-10-15 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | ASCLEMED USA INC. | db8e6702-88ac-4db2-9dd8-7d0ed997c2b5 | 2025-10-14 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreen Company | fa33f6ef-522b-4630-9716-92371d9cd24a | 2025-10-14 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Rite Aid Corporation | a8bb4f45-7a1a-4bf7-92ca-3afd508032f3 | 2025-10-09 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Health Pharma USA LLC | b15a7dcb-f143-4aea-8850-d0aacbf709b6 | 2025-10-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PD-Rx Pharmaceuticals, Inc. | 3f96aeb1-a533-4d36-9a1f-62fc094b6754 | 2025-10-08 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreens | f2eb9575-d527-44c7-aa5e-efabfd9a0278 | 2025-10-07 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bbc704e5-79f6-4c72-846b-cc30c5c43cb4 | 2025-10-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | f1ce15a3-9824-4eb5-910a-39078165f385 | 2025-10-07 | Warnings | M013 |
| BupropiDex | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 90cc9bcd-7891-4324-a1f4-f6df7a0457e0 | 2025-10-06 | Warnings | M013 |
| Dextabs | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 71b567df-844a-4563-b85a-f4592233f37d | 2025-10-06 | Warnings | M013 |
| Acetaminophen, Aspirin and Caffeine | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rising Pharma Holdings, Inc. | 50f72713-50f5-4bab-9e96-b9fa73c9df1f | 2025-10-06 | Warnings | M013 |
| OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL | ACETAMINOPHEN 160 MG / 5 ML | MEDWISE LIFESCIENCES INC. | 40507559-aee4-a603-e063-6394a90afc4f | 2025-10-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 004c39cd-b4f4-1cae-e063-6394a90a0697 | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | 43573e35-6776-446e-aa28-75c8edc5b98d | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | f8e5fab4-1212-4c60-a160-9b782f76a198 | 2025-10-03 | Warnings | M013 |
| CVS Acetaminophen | ACETAMINOPHEN | CVS Pharmacy | 3d71a0aa-5e03-0bdc-e063-6294a90a6634 | 2025-10-02 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | cc865351-34e8-4e8e-b8bf-23336c45bc61 | 2025-10-02 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Bryant Ranch Prepack | 8e40f8f1-03c5-444b-8b5e-4532c3146e47 | 2025-10-02 | Warnings | M013 |
| ASPIRIN 325 MG EC | ASPIRIN | Proficient Rx LP | 9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77 | 2025-10-01 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 948c5826-6f35-484d-bb3f-cecf6a4b5c13 | 6 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 948c5826-6f35-484d-bb3f-cecf6a4b5c13 | 6 |
| 198440 | APAP 500 MG Oral Tablet | SY | 948c5826-6f35-484d-bb3f-cecf6a4b5c13 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71009-109-01 | 71009010901 | 100 TABLET in 1 BOTTLE (71009-109-01) | 100 tablet | 2021-03-09 | 0000-00-00 | No | No | Current |