Instant Foam Non-alcohol PURE Hand Sanitizer
- Product NDC
- 11084-300
- 11-digit product format
- 110840300
- Labeler code
- 11084
- Product ID
- 11084-300_218bf8d3-a6db-4d18-8511-86adad611144
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZALKONIUM CHLORIDE
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- SC Johnson Professional USA, Inc.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-04-15
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- .13 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 11084-300 | 11084-300-01 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 11084-300 | 11084-300-27 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 11084-300 | 11084-300-40 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 11084-300 | 11084-300-97 | D | Discontinued by firm | 2026-08-11 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 11084-300-97 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 11084-300-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 11084-300-27 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 11084-300-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11084-300-97 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11084-300-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11084-300-27 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11084-300-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11084-300-97 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11084-300-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11084-300-27 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11084-300-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11084-300-97 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11084-300-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11084-300-27 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11084-300-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11084-300-97 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11084-300-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11084-300-27 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11084-300-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11084-300-97 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11084-300-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11084-300-27 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11084-300-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 11084-300-97 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 11084-300-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 11084-300-27 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 11084-300-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 11084-300-97 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 11084-300-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 11084-300-27 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 11084-300-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 11084-300-97 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 11084-300-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 11084-300-27 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 11084-300-01 | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Instant Foam Non-alcohol PURE Hand Sanitizer
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .13 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020365 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fc557f8d-7ebe-4434-a350-602efbbb9c6e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11084-300-01 | Instant Foam Non-alcohol PURE Hand Sanitizer | 47 mL in 1 BOTTLE, PLASTIC | LIQUID | 47 | 5 | |
| 11084-300-12 | Instant Foam Non-alcohol PURE Hand Sanitizer | 1200 mL in 1 BOTTLE, PLASTIC | LIQUID | 1200 | 5 | |
| 11084-300-27 | Instant Foam Non-alcohol PURE Hand Sanitizer | 1000 mL in 1 BOTTLE, PLASTIC | LIQUID | 1000 | 5 | |
| 11084-300-40 | Instant Foam Non-alcohol PURE Hand Sanitizer | 400 mL in 1 BOTTLE, PLASTIC | LIQUID | 400 | 5 | |
| 11084-300-66 | Instant Foam Non-alcohol PURE Hand Sanitizer | 1000 mL in 1 BOTTLE | LIQUID | 1000 | 5 | |
| 11084-300-97 | Instant Foam Non-alcohol PURE Hand Sanitizer | 296 mL in 1 BOTTLE, PLASTIC | LIQUID | 296 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11084-300 | INSTANT FOAM NON-ALCOHOL PURE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SC JOHNSON PROFESSIONAL USA, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241220_fc557f8d-7ebe-4434-a350-602efbbb9c6e.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 |
|---|---|---|---|---|---|---|
| Instant Foam Non-alcohol PURE Hand Sanitizer | BENZALKONIUM CHLORIDE | SC Johnson Professional USA, Inc. | fc557f8d-7ebe-4434-a350-602efbbb9c6e | 2024-12-18 | Warnings | 11084-300 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | PSN | fc557f8d-7ebe-4434-a350-602efbbb9c6e | 5 |
| 1020365 | benzalkonium chloride 1.3 MG/ML Topical Foam | SCD | fc557f8d-7ebe-4434-a350-602efbbb9c6e | 5 |
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | SY | fc557f8d-7ebe-4434-a350-602efbbb9c6e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11084-300-01 | 11084030001 | 47 mL in 1 BOTTLE, PLASTIC (11084-300-01) | 47 ml | 2020-04-15 | 0000-00-00 | No | No | Current |
| 11084-300-12 | 11084030012 | 1200 mL in 1 BOTTLE, PLASTIC (11084-300-12) | 1200 ml | 2020-04-15 | 0000-00-00 | No | No | Current |
| 11084-300-27 | 11084030027 | 1000 mL in 1 BOTTLE, PLASTIC (11084-300-27) | 1000 ml | 2020-04-15 | 0000-00-00 | No | No | Current |
| 11084-300-40 | 11084030040 | 400 mL in 1 BOTTLE, PLASTIC (11084-300-40) | 400 ml | 2020-10-01 | 0000-00-00 | No | No | Current |
| 11084-300-66 | 11084030066 | 1000 mL in 1 BOTTLE (11084-300-66) | 1000 ml | 2023-02-17 | No | No | Current | |
| 11084-300-97 | 11084030097 | 296 mL in 1 BOTTLE, PLASTIC (11084-300-97) | 296 ml | 2020-04-15 | 0000-00-00 | No | No | Current |