Enteric Coated Aspirin
- Product NDC
- 49483-331
- 11-digit product format
- 494830331
- Labeler code
- 49483
- Product ID
- 49483-331_2d9d52a2-747c-1f7f-e063-6394a90aa794
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aspirin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Time-Cap Labs, Inc
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-01-04
- Substance
- ASPIRIN
- Active strength
- 325 mg/3251
- 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
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-331-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-331-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-331-00 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-331-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-331-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-331-00 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-331-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-331-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-331-00 | 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
- Enteric Coated Aspirin
- Brand name suffix
- Regular Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/3251 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198467 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5fbd8bb3-46f9-4089-9a21-b6af97a06106 | Available on FDA.report |
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 | Related label |
|---|---|---|
| 49483-331-00 | 2025-02-10 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
| 49483-331-01 | 2025-02-10 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
| 49483-331-10 | 2025-02-10 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
| 49483-331-00 | 2025-01-30 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
| 49483-331-01 | 2025-01-30 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
| 49483-331-10 | 2025-01-30 | 331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-331-00 | Enteric Coated AspirinRegular Strength | 100000 in 1 CARTON | TABLET, DELAYED RELEASE | 100000 | 8 | |
| 49483-331-01 | Enteric Coated AspirinRegular Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | 8 | |
| 49483-331-10 | Enteric Coated AspirinRegular Strength | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-331-01 | EA - Each | 49483-331 | 4cadaf05-9066-48aa-9702-2f3912b10d1b | 1 | 2014-06-03 |
| 49483-331-10 | EA - Each | 49483-331 | e229c0f3-6ea0-40b7-82ac-3e47bb1ccbf0 | 1 | 2013-02-13 |
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 |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1c083e29-8732-4ecd-ab4b-9038acbd0b9d | 2025-05-22 | Warnings | M013 |
| TYLENOL For Children Plus Adults | ACETAMINOPHEN | Kenvue Brands LLC | 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 | 2025-05-21 | Warnings | M013 |
| Children Acetaminophen | ACETAMINOPHEN | AARNA USA INC. | 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 | 2025-05-16 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 35478de8-50d0-5d0a-e063-6294a90a88ba | 2025-05-16 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 95f4b628-6d35-4f6b-91f9-b2d117f8e821 | 2025-05-16 | Warnings | M013 |
| good neighbor pharmacy childrens pain and fever | ACETAMINOPHEN | Amerisource Bergen | 268a789b-8f31-4739-9777-523249cac326 | 2025-05-13 | Warnings | M013 |
| ASPIRIN LOW DOSE | ASPIRIN LOW DOSE | AARNA USA INC. | 347edc8f-6391-b75e-e063-6394a90a1cf5 | 2025-05-06 | Warnings | M013 |
| Good Neighbor Pharmacy Infants Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2 | 2025-05-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 34157f6a-3031-4388-e063-6394a90a670f | 2025-05-01 | Warnings | M013 |
| ASPIRIN | ASPIRIN | HF Acquisition Co LLC, DBA HealthFirst | 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4 | 2025-05-01 | Warnings, Adverse reactions | M013 |
| Aspirin 81mg Enteric Coated | ASPIRIN | Advanced Rx LLC | 606067bb-b07f-444e-9465-d1e187735f3a | 2025-05-01 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 33f0e822-28af-9bb2-e063-6294a90a5175 | 2025-04-29 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 27fcca07-f845-77fe-e063-6394a90aa2f8 | 2025-04-24 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 46a6bbb9-ccd1-47a8-9e58-485f71f57063 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 061c91d5-5aa8-4556-a344-197b7e8a10b8 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 | 2025-04-24 | Warnings | M013 |
| Extra Strength No-Pain | ACETAMINOPHEN | Safrel Pharmaceuticals, LLC. | 873f01dd-0701-5fd3-e053-2a95a90a6463 | 2025-04-23 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Chain Drug Consortium | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 2025-04-16 | Warnings | M013 |
| Premsyn pms Premenstrual Pain Relief | ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 2025-04-14 | Warnings | M013 |
| BackAid Max | ACETAMINOPHEN, PAMABROM | Kobayashi Healthcare International, Inc. | fb9a5647-b7c9-4820-b148-91060e34cb83 | 2025-04-14 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | PSN | 5fbd8bb3-46f9-4089-9a21-b6af97a06106 | 8 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | PSN | fd256c4a-a176-45dc-b757-fc01eb105008 | 8 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | SCD | 5fbd8bb3-46f9-4089-9a21-b6af97a06106 | 8 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | SCD | fd256c4a-a176-45dc-b757-fc01eb105008 | 8 |
| 198467 | ASA 325 MG Delayed Release Oral Tablet | SY | 5fbd8bb3-46f9-4089-9a21-b6af97a06106 | 8 |
| 198467 | ASA 325 MG Delayed Release Oral Tablet | SY | fd256c4a-a176-45dc-b757-fc01eb105008 | 8 |
| 198467 | aspirin 325 MG Enteric Coated Oral Tablet | SY | 5fbd8bb3-46f9-4089-9a21-b6af97a06106 | 8 |
| 198467 | aspirin 325 MG Enteric Coated Oral Tablet | SY | fd256c4a-a176-45dc-b757-fc01eb105008 | 8 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | PSN | e05140fa-9766-4f97-bffc-e36a01b9d38f | 7 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | SCD | e05140fa-9766-4f97-bffc-e36a01b9d38f | 7 |
| 198467 | ASA 325 MG Delayed Release Oral Tablet | SY | e05140fa-9766-4f97-bffc-e36a01b9d38f | 7 |
| 198467 | aspirin 325 MG Enteric Coated Oral Tablet | SY | e05140fa-9766-4f97-bffc-e36a01b9d38f | 7 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | PSN | 51b11ee1-f881-4e12-8298-6994414ce0f7 | 6 |
| 198467 | aspirin 325 MG Delayed Release Oral Tablet | SCD | 51b11ee1-f881-4e12-8298-6994414ce0f7 | 6 |
| 198467 | ASA 325 MG Delayed Release Oral Tablet | SY | 51b11ee1-f881-4e12-8298-6994414ce0f7 | 6 |
| 198467 | aspirin 325 MG Enteric Coated Oral Tablet | SY | 51b11ee1-f881-4e12-8298-6994414ce0f7 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49483-331-00 | 49483033100 | 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00) | 2011-04-10 | 0000-00-00 | No | No | Current |
| 49483-331-01 | 49483033101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-01) | 2011-04-10 | 0000-00-00 | No | No | Current |
| 49483-331-10 | 49483033110 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-10) | 2011-04-10 | 0000-00-00 | No | No | Current |