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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | 55e996cd-ef22-4e09-a05c-8aa994e4540b | 2026-06-12 | Warnings | M013 |
| CHILDRENS TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3162733b-9382-39f1-e063-6294a90ac420 | 2026-06-12 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 | 2026-06-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 54010ddf-25d1-2016-e063-6294a90a877d | 2026-06-11 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 983debdf-4a61-4dde-ba34-567fdd17720e | 2026-06-11 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALGREENS | 40b4fe91-b1dd-147c-e063-6294a90a807d | 2026-06-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PUBLIX SUPERMARKETS, INC | 3f17fa06-4932-b8ec-e063-6294a90a0381 | 2026-06-09 | Warnings | M013 |
| Sleep Aid Plus Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | e3929179-dad2-4f7e-a971-dbf80f2b5e1b | 2026-06-08 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Pinnacle RX LLC | 53c11fb4-ba31-b5e5-e063-6394a90a9c1a | 2026-06-08 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | 9655c38a-126b-459e-b31d-0aa33d9eb522 | 2026-06-08 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | dce938f5-eeba-4a76-9261-2b1324c39a31 | 2026-06-08 | Warnings | M013 |
| Childrens Mapap | ACETAMINOPHEN | Bryant Ranch Prepack | 69c90cc8-846a-42cf-933a-108671689e8f | 2026-06-05 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Rugby Laboratories | 63fcd93a-b1db-44ba-8f2b-055a7deb205d | 2026-06-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ASCLEMED USA INC. | 707a9ea7-8f4e-4274-97bd-b8071a0ee06b | 2026-06-04 | Warnings | M013 |
| Aspirin Adult low dose | ACETYLSALICYCLIC ACID | Medline Industries, LP | 6dd6501f-841c-4994-e053-2a91aa0ae231 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5e6f2a-e813-0666-e053-6394a90a66a7 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5d92c2-4bbe-8ad1-e053-6294a90a65b6 | 2026-06-04 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Unit Dose Solutions, Inc. | 537219ac-552a-a30e-e063-6394a90aa9d1 | 2026-06-04 | Warnings | M013 |
| Pain Relief childrens | ACETAMINOPHEN | CVS PHARMACY | ff878f56-125a-4de7-b063-029f7030733d | 2026-06-04 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | CVS Pharmacy | 749e2be2-594a-4052-8fa5-45c9ade2d23c | 2026-06-03 | 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 |