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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 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 |