Adult Low Dose Aspirin
- Product NDC
- 16103-356
- 11-digit product format
- 161030356
- Labeler code
- 16103
- Product ID
- 16103-356_9c7048f1-9ac5-431b-9279-ee6ce88e6d71
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aspirin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Pharbest Pharmaceuticals, Inc.
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-01-12
- 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 | 16103-356-09 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 16103-356-11 | 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 | 16103-356-09 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 16103-356-11 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 16103-356-09 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 16103-356-11 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 16103-356-09 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 16103-356-11 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 16103-356-11 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 16103-356-09 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- Adult Low Dose Aspirin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 81 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308416 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4522f745-b88d-4021-a5dc-0161f1967dc9 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|
| 16103-356-09 | 2025-01-30 | Drug Facts |
| 16103-356-11 | 2025-01-30 | Drug Facts |
| 16103-356-09 | 2023-06-08 | Drug Facts |
| 16103-356-11 | 2023-06-08 | Drug Facts |
| 16103-356-09 | 2023-01-30 | Drug Facts |
| 16103-356-11 | 2023-01-30 | Drug Facts |
| 16103-356-09 | 2021-03-29 | Drug Facts |
| 16103-356-11 | 2021-03-29 | Drug Facts |
| 16103-356-09 | 2020-01-31 | Drug Facts |
| 16103-356-11 | 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16103-356-09 | Adult Low Dose Aspirin | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 4 | |
| 16103-356-09 | Adult Low Dose Aspirin | 120 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 120 | 4 | |
| 16103-356-11 | Adult Low Dose Aspirin | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16103-356-09 | EA - Each | 16103-356 | 2a4fc101-b4b3-4006-94da-4dcc4f99468a | 1 | 2012-07-24 |
| 16103-356-11 | EA - Each | 16103-356 | 5401e9c5-7206-4514-b71f-0844577ed8af | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Eye Clean | EYE WASH | HART Health | 41f53e2e-c2bc-4bf1-a541-3bcb2cf63002 | 2025-12-31 | Warnings | M |
| NUTRALOX | CALCIUM CARBONATE | HART Health | 3941b84e-3b4b-46eb-851b-979bac1ae997 | 2025-12-31 | Warnings | M |
| PVP Iodine | POVIDONE-IODINE | HART Health | 06b085dd-934d-40e9-aa0d-2dd9cdccd535 | 2025-12-31 | Warnings | M |
| WOUND WIPES | BENZALKONIUM CHLORIDE | HART Health | 4942195e-2941-4111-8ab7-2891c316bd27 | 2025-12-31 | Warnings | M |
| MG DermaGel 62 | ETHYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | e6b2cc57-11a6-4808-a30f-8118a8de9fc6 | 2025-12-29 | Warnings | M |
| MG FoamSan | BENZALKONIUM CHLORIDE | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | c5311836-674a-400b-a0d3-92f959d92682 | 2025-12-29 | Warnings | M |
| CETAFEN EXTRA | ACETAMINOPHEN | HART Health | 38db0b09-37f8-4fed-903e-81e89486b39b | 2025-12-24 | Warnings | M |
| CETAFEN | ACETAMINOPHEN | HART Health | c1162bab-377d-4e17-9417-ccd20d29148b | 2025-12-24 | Warnings | M |
| CETAFEN COUGH and COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | HART Health | 44da0d8c-4a12-4122-99da-781e2809e1a8 | 2025-12-24 | Warnings | M |
| Adult Low Dose Aspirin | ASPIRIN | Pharbest Pharmaceuticals, Inc. | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 2025-12-24 | Warnings | M 16103-356 |
| MG DermaFoam | BENZALKONIUM CHLORIDE | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 4a43a605-f333-4c76-a476-476a9cc2e13a | 2025-12-23 | Warnings | M |
| MG DermaGel 70 | ETHYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 56ac723b-3ede-4c94-bf4a-0572a7b42b59 | 2025-12-23 | Warnings | M |
| MG DermaSan 72 | ISOPROPYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | cccdefbc-09ef-417f-9b7a-1b254ae6e438 | 2025-12-23 | Warnings | M |
| MG FoamSan 70 | ETHYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 11fc23dd-80e1-4df1-8c19-f759ecb34f1a | 2025-12-23 | Warnings | M |
| Hand Sanitizer Solution 101 | BENZALKONIUM CHLORIDE | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 81fa10d3-6dbb-4a72-bfff-2dd795f94968 | 2025-12-23 | Warnings | M |
| MG DermaWash | BENZALKONIUM CHLORIDE | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 0bb37363-418f-46c7-8c39-9ef9aa5023f7 | 2025-12-23 | Warnings | M |
| MG DermaGel 62 LV | ETHYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 437a508d-31ba-49b4-b821-4bf57b596e33 | 2025-12-23 | Warnings | M |
| Antibacterial Liquid Hand | BENZALKONIUM CHLORIDE | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | ea0a5970-e95f-4090-bbe3-7df9e04393b5 | 2025-12-23 | Warnings | M |
| MG DermaClean | N/A | Morgan Gallacher Inc. | ed3d983e-0a6e-4de4-832a-0020f7711011 | 2025-12-23 | Warnings | M |
| MG DermaSan | N/A | Morgan Gallacher Inc. | d4c0de39-8570-4a05-a5e3-3752545ed95f | 2025-12-23 | Warnings | M |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | ef9d5cea-86f1-44c2-bca4-70ff5fa16356 | 11 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | ef9d5cea-86f1-44c2-bca4-70ff5fa16356 | 11 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | ef9d5cea-86f1-44c2-bca4-70ff5fa16356 | 11 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | ef9d5cea-86f1-44c2-bca4-70ff5fa16356 | 11 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 4 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 4 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 4 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 4 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | 1b2e6566-cb7c-7a7d-e063-6394a90af97c | 2 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | 1b2e6566-cb7c-7a7d-e063-6394a90af97c | 2 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | 1b2e6566-cb7c-7a7d-e063-6394a90af97c | 2 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | 1b2e6566-cb7c-7a7d-e063-6394a90af97c | 2 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | 466f6fa5-79f9-4f53-971d-a5254b0750e3 | 1 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | 47b595dd-51ff-4400-91d5-c814a5c80eb4 | 1 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | b427f43b-6c79-4141-9709-8da63d198cc8 | 1 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | 466f6fa5-79f9-4f53-971d-a5254b0750e3 | 1 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | 47b595dd-51ff-4400-91d5-c814a5c80eb4 | 1 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | b427f43b-6c79-4141-9709-8da63d198cc8 | 1 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | 47b595dd-51ff-4400-91d5-c814a5c80eb4 | 1 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | b427f43b-6c79-4141-9709-8da63d198cc8 | 1 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | 466f6fa5-79f9-4f53-971d-a5254b0750e3 | 1 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | 466f6fa5-79f9-4f53-971d-a5254b0750e3 | 1 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | 47b595dd-51ff-4400-91d5-c814a5c80eb4 | 1 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | b427f43b-6c79-4141-9709-8da63d198cc8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16103-356-09 | 16103035609 | 1 BOTTLE, PLASTIC in 1 CARTON (16103-356-09) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2007-01-12 | 0000-00-00 | No | No | Current |
| 16103-356-11 | 16103035611 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-356-11) | 2007-01-12 | 0000-00-00 | No | No | Current |