Betadine
- Product NDC
- 67618-151
- 11-digit product format
- 676180151
- Labeler code
- 67618
- Product ID
- 67618-151_26bf0dc4-726a-4f00-a3f8-1672431c6899
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- POVIDONE-IODINE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Atlantis Consumer Healthcare, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1996-07-01
- Substance
- POVIDONE-IODINE
- Active strength
- .075 mg/mL
- 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 | 67618-151 | 67618-151-16 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 67618-151 | 67618-151-17 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 67618-151 | 67618-151-32 | D | Discontinued by firm | 2026-10-05 |
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 | 67618-151-17 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 67618-151-32 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 67618-151-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 67618-151-17 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 67618-151-32 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 67618-151-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 67618-151-17 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 67618-151-32 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 67618-151-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 67618-151-17 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 67618-151-32 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 67618-151-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 67618-151-17 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 67618-151-32 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 67618-151-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 67618-151-17 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 67618-151-32 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 67618-151-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 67618-151-32 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 67618-151-32 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 67618-151-32 | 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
- Betadine
- Brand name suffix
- Surgical Scrub
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POVIDONE-IODINE | .075 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85H0HZU99M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ad39e11-ea1e-44a4-8224-93f8135436c2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67618-151-01 | BetadineSurgical Scrub | 3780 mL in 1 BOTTLE | SOLUTION | 3780 | 11 | |
| 67618-151-04 | BetadineSurgical Scrub | 118 mL in 1 BOTTLE | SOLUTION | 118 | 11 | |
| 67618-151-16 | BetadineSurgical Scrub | 473 mL in 1 BOTTLE | SOLUTION | 473 | 11 | |
| 67618-151-17 | BetadineSurgical Scrub | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 67618-151-17 | BetadineSurgical Scrub | 473 mL in 1 BOTTLE | SOLUTION | 473 | 11 | |
| 67618-151-32 | BetadineSurgical Scrub | 946 mL in 1 BOTTLE | SOLUTION | 946 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67618-151-01 | ML - Milliliter | 67618-151 | a2eefddd-3b28-4a3b-bfd5-c9f865241eb6 | 1 | 2012-07-24 |
| 67618-151-04 | ML - Milliliter | 67618-151 | 878df6d8-51c5-40e4-99fb-7af1bd815227 | 1 | 2012-07-24 |
| 67618-151-16 | ML - Milliliter | 67618-151 | f96e02d7-14c0-4bc9-bee0-6918cf56f12e | 1 | 2012-07-24 |
| 67618-151-17 | ML - Milliliter | 67618-151 | 46650e95-655b-48d8-a6e3-3c710971a77f | 1 | 2012-07-24 |
| 67618-151-32 | ML - Milliliter | 67618-151 | f5eb7cb8-17e2-43df-b367-21f5d019428f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP] | 1 | |
| POVIDONE-IODINE | ACTIVE MOIETY | 85H0HZU99M | BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP] | 1 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1149658 | BETADINE 7.5 % Medicated Liquid Soap | PSN | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 211747 | povidone-iodine 7.5 % Medicated Liquid Soap | PSN | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 1149658 | povidone-iodine 75 MG/ML Medicated Liquid Soap [Betadine] | SBD | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 211747 | povidone-iodine 75 MG/ML Medicated Liquid Soap | SCD | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 1149658 | Betadine 75 MG/ML Medicated Liquid Soap | SY | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 1149658 | Betadine Skin Cleanser 7.5 % Medicated Liquid Soap | SY | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 1149658 | Betadine Surgical Scrub 7.5 % Medicated Liquid Soap | SY | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
| 211747 | povidone-iodine 7.5 % Medicated Liquid Soap | SY | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67618-151-01 | 67618015101 | 3780 mL in 1 BOTTLE (67618-151-01) | 3780 ml | 1996-07-01 | 0000-00-00 | No | No | Current |
| 67618-151-04 | 67618015104 | 118 mL in 1 BOTTLE (67618-151-04) | 118 ml | 1996-07-01 | 0000-00-00 | No | No | Current |
| 67618-151-16 | 67618015116 | 473 mL in 1 BOTTLE (67618-151-16) | 473 ml | 1996-07-01 | 0000-00-00 | No | No | Current |
| 67618-151-17 | 67618015117 | 1 BOTTLE in 1 CARTON (67618-151-17) > 473 mL in 1 BOTTLE | 1 bottle | 1996-07-01 | 0000-00-00 | No | No | Current |
| 67618-151-32 | 67618015132 | 946 mL in 1 BOTTLE (67618-151-32) | 946 ml | 1996-07-01 | 0000-00-00 | No | No | Current |