Regular Strength Enteric coated aspirin

Product NDC
17856-0922
11-digit product format
178560922
Labeler code
17856
Product ID
17856-0922_38521896-85cf-7eb4-e063-6294a90a1fb0
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-07-01
Substance
ASPIRIN
Active strength
325 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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Enteric coated aspirinASPIRINATLANTIC BIOLOGICALS CORP.e1c8d0ed-da1d-4b1a-9a85-7b8532775f872025-06-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if the stomach bleeding warning applies to you you are taking a diuretic you have a history of stomach problems, such as heartburn you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away pain gets worse or lasts more than 10 days redness or swelling is present fever gets worse or lasts more than 3 days any new symptoms occur ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Regular Strength Enteric coated aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0922-12024-04-18C16284748780-1d6a99b39-3932-a426-e053-dadaa90af4c2ASPIRIN EC 325 MG
17856-0922-12024-01-30C16284748780-1d6a99b39-3932-a426-e053-dadaa90af4c2ASPIRIN EC 325 MG
17856-0922-12022-09-14C16284748780-1d6a99b39-3932-a426-e053-dadaa90af4c2ASPIRIN EC 325 MG
17856-0922-12022-01-28C16284748780-1d6a99b39-3932-a426-e053-dadaa90af4c2ASPIRIN EC 325 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0922-1Regular Strength Enteric coated aspirin100 in 1 BOX, UNIT-DOSETABLET, COATED1004
17856-0922-2Regular Strength Enteric coated aspirin1 in 1 POUCHTABLET, COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0922-1EA - Each17856-09221d248303-e3db-40de-bf7b-96691ea4562812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0922REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 2 package rows20240420_e1c8d0ed-da1d-4b1a-9a85-7b8532775f87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467aspirin 325 MG Delayed Release Oral TabletSCDe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467ASA 325 MG Delayed Release Oral TabletSYe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467aspirin 325 MG Enteric Coated Oral TabletSYe1c8d0ed-da1d-4b1a-9a85-7b8532775f874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0922-117856092201100 POUCH in 1 BOX, UNIT-DOSE (17856-0922-1) / 1 TABLET, COATED in 1 POUCH (17856-0922-2) 100 pouch2024-04-180000-00-00NoNoCurrent
17856-0922-2178560922021 in 1 POUCHHistorical