Sterile Alcohol
- Product NDC
- 63868-980
- 11-digit product format
- 638680980
- Labeler code
- 63868
- Product ID
- 63868-980_2ad55938-0101-3a3f-e063-6394a90af7f5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Isopropyl alcohol
- Dosage form
- SWAB
- Route
- TOPICAL
- Labeler
- Chain Drug Marketing Association Inc
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-06-30
- Marketing end
- 2026-11-30
- Substance
- ISOPROPYL ALCOHOL
- Active strength
- .7 mL/1
- NDC exclude flag
- No
- 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 |
|---|---|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 63868-980-01 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 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 | 63868-980-01 | 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 | 63868-980-01 | 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 | 63868-980-01 | 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
- Sterile Alcohol
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ISOPROPYL ALCOHOL | .7 mL/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ND2M416302 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 797544 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55922632-3768-4450-9389-ba7d7d91f2c9 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-01-03 | 63868-980 Chain Drug Marketing Association IPA Pad |
| 2024-01-30 | 63868-980 Chain Drug Marketing Association IPA Pad |
| 2021-01-25 | 63868-980 Chain Drug Marketing Association IPA Pad |
| 2020-01-31 | 63868-980 Chain Drug Marketing Association IPA Pad |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-980-01 | Sterile Alcohol | 1 in 1 PACKET | SWAB | 1 | 8 | |
| 63868-980-01 | Sterile Alcohol | 100 in 1 BOX | SWAB | 100 | 8 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC] | 3 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC] | 3 |
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 |
|---|---|---|---|---|---|---|
| Safly BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 5cd9043e-daf2-43eb-9568-54775fc4f84a | 2024-05-15 | Warnings | M003 |
| Noshinku Bergamot Hand Sanitizer | ALCOHOL | Noshinku | 53fea81e-4482-6fae-e054-00144ff8d46c | 2024-05-14 | Warnings | M003 |
| Noshinku Eucalyptus Hand Sanitizer | ALCOHOL | Noshinku | 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 | 2024-05-14 | Warnings | M003 |
| Noshinku Lavender Hand Sanitizer | ALCOHOL | Noshinku | a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf | 2024-05-14 | Warnings | M003 |
| LEADER 2% Mild Iodine Tincture | IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID | Cardinal Health, 110 dba Leader | 7f810b92-60f6-2f72-e053-2991aa0ab973 | 2024-05-13 | Warnings | M003 |
| Leader Decolorized Iodine | ALCOHOL LIQUID | Cardinal Health, 110 dba Leader | 822f6f28-956f-dd82-e053-2991aa0ae752 | 2024-05-13 | Warnings | M003 |
| Inverness Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a2995-334c-2e93-e063-6294a90aecf7 | 2024-05-09 | Warnings | M003 |
| Helzberg Diamonds Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a3776-0edd-26f3-e063-6294a90a740d | 2024-05-09 | Warnings | M003 |
| Ulta Beauty Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a37f4-8718-3e40-e063-6294a90acaad | 2024-05-09 | Warnings | M003 |
| Guardian Vaginal | BENZALKONIUM CHLORIDE | Eastern Century Pharmaceuticals | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 2024-04-24 | Warnings | M003 |
| Inverness Hygienic Ear Care Antiseptic | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b | 2024-04-18 | Warnings | M003 |
| Lovisa Piercing Care Solution | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 | 2024-04-18 | Warnings | M003 |
| CliniClean BZK Cleansing Contains Benzalkonium Chloride | BENZALKONIUM CHLORIDE | HR HealthCare | b6916466-0931-408f-a430-0797a449c32e | 2024-04-18 | Warnings | M003 |
| Handy Solutions First Aid Kit | BENZALKONIUM CHLORIDE | Navajo Manufacturing Company Inc. | 130237ff-3db4-1288-e063-6394a90ab1af | 2024-04-16 | Warnings | M003 |
| BZK | BENZALKONIUM CHLORIDE | Henry Schein Inc. | ff877b63-fa58-4770-a882-694eda33203b | 2024-04-02 | Warnings | M003 |
| First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d | 2024-04-01 | Warnings | M003 |
| Antiseptic Towelette TOALLITAS ANTISEPTICAS | BENZALKONIUM CHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | b267e186-cf7a-458f-9c28-a48a8554af40 | 2024-04-01 | Warnings | M003 |
| Antiseptic Povidone Iodine Prep Pad | POVIDONE-IODINE | M-star (Hubei) Health&Care Products Co., Ltd. | fc76c1f3-b48e-4276-890d-5b8e5a894e62 | 2024-04-01 | Warnings | M003 |
| Novex Hand Sanitizer | BENZALKONIUM CHLORIDE | Natural Essentials, Inc. | 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 | 2024-03-20 | Warnings | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE 0.13% | Trifecta Pharmaceuticals USA, LLC. | 13f1c70f-3b44-8eef-e063-6294a90af634 | 2024-03-18 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 55922632-3768-4450-9389-ba7d7d91f2c9 | 8 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 55922632-3768-4450-9389-ba7d7d91f2c9 | 8 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 55922632-3768-4450-9389-ba7d7d91f2c9 | 8 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 55922632-3768-4450-9389-ba7d7d91f2c9 | 8 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 55922632-3768-4450-9389-ba7d7d91f2c9 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-980-01 | 63868098001 | 100 PACKET in 1 BOX (63868-980-01) / 1 SWAB in 1 PACKET | 100 packet | 2017-03-10 | 2026-11-30 | No | No | Current |