Aspirin
- Product NDC
- 68071-3425
- 11-digit product format
- 680713425
- Labeler code
- 68071
- Product ID
- 68071-3425_5a869477-29e0-2b45-e063-6294a90adcf6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aspirin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-05-01
- Substance
- ASPIRIN
- Active strength
- 81 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-3425-9 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-3425-9 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-3425-9 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-3425-9 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Aspirin
- Brand name suffix
- Low Dose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 81 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3425-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-940d-d83d-e063-dadaa90ab31f | Major 44-600A |
| 68071-3425-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-940d-d83d-e063-dadaa90ab31f | Major 44-600A |
| 68071-3425-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-940d-d83d-e063-dadaa90ab31f | Major 44-600A |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3425-9 | AspirinLow Dose | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3425 | ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 1 package rows | 20230629_fd199a7f-76ca-fefc-e053-6294a90a821d.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 |
|---|---|---|---|---|---|---|
| Menstrual Relief Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | United Natural Foods, Inc. dba UNFI | 807598ef-9f03-48df-b076-3ee95ef4b06c | 2026-01-05 | Warnings | M013 |
| Pain Relief Extra Strength, Non-Aspirin | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 1fb5e871-45fd-46fe-bf73-5192f8316e8e | 2026-01-02 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Valu Merchandisers Company | 0005aafa-08f8-4990-a54d-cc097195708f | 2026-01-02 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | Walmart Inc. | 152bb455-da5b-ae13-e063-6394a90acab0 | 2026-01-01 | Warnings | M013 |
| Dr. Cocoa for Children Pain and Fever | ACETAMINOPHEN | Infirst Healthcare Inc. | 486ea294-6d18-a907-e063-6294a90ad284 | 2026-01-01 | Warnings | M013 |
| ED APAP | ACETAMINOPHEN | EDWARDS PHARMACEUTICALS, INC. | f76d5fff-ebea-40f9-aad3-4064a0c863f0 | 2025-12-31 | Warnings | M013 |
| EXTRA STRENGTH PAIN RELIEF | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 99ec63ef-aa28-c2fb-e053-2a95a90a9f6d | 2025-12-31 | Warnings | M013 |
| Puregen Labs Acetaminophen | ACETAMINOPHEN | Advanced Rx LLC | 474580af-f6b0-e440-e063-6394a90aaada | 2025-12-31 | Warnings | M013 |
| Liquid Acetaminophen | ACETAMINOPHEN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | a7dbd4c0-53eb-4368-917b-1432c09ce6b4 | 2025-12-31 | Warnings | M013 |
| Llorens Care Children Acetaminophen | ACETAMINOPHEN | Llorens Pharmaceutical International Division, Inc. | 2a46d7d2-293b-5024-e063-6294a90a31aa | 2025-12-31 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE) | Walgreens | 3a801457-c5d0-b134-e063-6294a90ac5cb | 2025-12-31 | Warnings | M013 |
| Daytime and Nighttime Severe Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Genexa Inc. | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2025-12-30 | Warnings | M013 |
| BioElectro Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Genomma Lab USA | 683a0fba-921c-48e7-a391-180c04f0d1c4 | 2025-12-30 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | 0181af13-da32-4431-be39-c31fdfac9202 | 2025-12-29 | Warnings | M013 |
| Gemma Cut the Cramp | ASPIRIN, CAFFEINE | Rally Labs LLC | 16c9a296-077a-8e12-e063-6294a90a1b8b | 2025-12-29 | Warnings | M013 |
| Blowfish | ASPIRIN, CAFFEINE | Rally Labs LLC | 0d3798bc-04ef-584e-821b-7aa76036b7d1 | 2025-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Pioneer Life Sciences, LLC | ac9efd62-8fee-b777-e053-2995a90a3783 | 2025-12-29 | Warnings | M013 |
| Childrens Pain Relief and Fever Reducer Oral Suspension Cherry | ACETAMINOPHEN | Puro Pharma Inc. | a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009 | 2025-12-27 | Warnings | M013 |
| Cystex PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Clarion Brands, LLC | 9668a2ca-729e-4172-80b5-33e6c5175ba4 | 2025-12-27 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | fd199a7f-76ca-fefc-e053-6294a90a821d | 3 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | fd199a7f-76ca-fefc-e053-6294a90a821d | 3 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | fd199a7f-76ca-fefc-e053-6294a90a821d | 3 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | fd199a7f-76ca-fefc-e053-6294a90a821d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68071-3425-3 | 68071342503 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68071-3425-3) | 2026-09-02 | No | No | Current |
| 68071-3425-9 | 68071342509 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68071-3425-9) | 2023-06-01 | No | No | Current |